Associate, Regulatory Affairs Resume Samples

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E Pacocha

Ellsworth

Pacocha

8527 Leta Alley

Boston

+1 (555) 203 7135

8527 Leta Alley

Boston

Phone

p +1 (555) 203 7135

Experience Experience

San Francisco, CA

Senior Associate Regulatory Affairs

San Francisco, CA

Roberts-Braun

San Francisco, CA

Senior Associate Regulatory Affairs

Work on special projects as they arise
Represents Global Regulatory Affairs at research and development meetings and presents agreed upon regulatory positions. May serve as a lead regulatory representative to an assigned product or project team
With oversight, serves as a liaison with regulatory agencies pertaining to assigned products. Assists in the preparation of agency meeting packages and strategies for agency meetings
Assist in template development and maintenance
Support regional regulatory filing activities (e.g. core CTA/IMPD development and submission, support for pre-MAA filing, regulatory authority meeting preparations)
Provide primary authorship to routine regulatory correspondence (e.g. annual reports, investigator packages)
Support the development and execution of GRT goals

Philadelphia, PA

Senior Associate, Regulatory Affairs

Philadelphia, PA

Abshire, Ledner and Nolan

Philadelphia, PA

Senior Associate, Regulatory Affairs

Provide leadership and advocacy for US Operations for commercialization strategies and competitive activities with trade associations, and government agencies
Manage interactions with FDA or other regulatory authorities for assigned projects
Developing professional relationships with FDA personnel to help ensure organization adheres to laws and regulations, and receives proper guidance
Understands and applies relevant GSARA processes
Analyze and report to management change in regulations or impending new regulations
Provide organizational training and updates across Zoetis regarding actions of USDA/CVB and FDA/CVM that might impact U.S. Operations business opportunities
Develop excellent relationships with internal functional groups, contract manufacturing organizations, and partners

present

Detroit, MI

Associate Regulatory Affairs Director

Detroit, MI

Hayes, Howell and Berge

present

Detroit, MI

Associate Regulatory Affairs Director

present

Provided relevant regulatory support for new product launch activities, including re-dressing activities
Be responsible for registration activity for new and existing products in China
Manage regulatory submissions process, prepare high quality submission documentation to support registration activities
Establish and strengthen proactive dialog and communication strategies with regulatory authorities (CFDA, CDE, institute for drug control, and so on) to influence environment and sharp policy
Drive communications and negotiations with regulatory authorities to expedite, secure and optimize regulatory approvals concordant with company goals
Work with regulatory officials and their think-tanks to provide them with scientific materials or information on up-to-date international standards or regulatory trends
Provide regulatory advice to global, area regulatory colleagues and other functional colleagues, in particular, QA, Supply Chain and Commercial

Education Education

Bachelor’s Degree in Life Sciences

University of Pittsburgh

Bachelor’s Degree in Life Sciences

Skills Skills

Excellent verbal and written communication skills
Attention to detail
Ability to plan and schedule multiple priorities in a concurrent fashion
Ability to review, collate and summarize scientific and technical data
Excellent problem solving and analytical skills
Good written and oral communication skills
Ability to work well within cross-functional teams
Complete work with minimal supervision and ability to work independently

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15 Associate, Regulatory Affairs resume templates

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Associate Regulatory Affairs Director CMC Resume Examples & Samples

At least bachelor degree in Chemistry or Pharmacy (or equivalent degree)
A minimum of 10 years industry experience; pharma, CRO or academic with at least 6 years’ experience directly in Regulatory Affairs or in CMC regulatory or CMC role within product development in the manufacturing field
Recent CMC experiences with, next to small molecules, development or manufacturing of biologicals, or vaccines or devices, preferably in a regulatory environment
Experience in managing direct reports is preferred

Associate Regulatory Affairs Co-op Student Resume Examples & Samples

Prepare and maintain regulatory affairs products compliance documents
Support regulatory affairs activities related to Canada’s Chemical Management Plan
Respond to requests from internal and external customers
Monitor the Canada Gazette for Environment and Health Canada updates
All other day to day regulatory affairs duties and tasks as assigned
University enrolment in Chemistry, Biology or related science program
Excellent computer skills, experience with SAP is an asset
Ability to manage multiple projects and tasks concurrently and effectively
Proficient communication (written and verbal), interpersonal and problem solving skills

Associate, Regulatory Affairs Operations Resume Examples & Samples

Publish and archive ANDAs, NDAs, INDs, DMFs, annual reports and safety reports
Utilize Electronic Submission Gateway (ESG) to submit submissions to FDA centers such as CDER, CBER, and OC
Responsible for ensuring the compliance of deliverables to applicable regulations, guidance requirements. Ensures that documents are formatted and named in accordance with FDA, ICH guidelines & internal guidelines/SOPs
Responsible for ensuring the compliance of drug listing, establishment registration and Self-ID with FDA
Utilize tools for document management, tracking, publishing and eCTDs
Act as first level help desk to provide general support with respect to processes and operational activities (i.e. SPL, eCTD or any other use system/ processes). Resolve publishing and submission issues
Engage in life cycle management of submission documents (if necessary) to ensure document integrity
Track and monitor metrics, maintains submission tracking tool
Escalates issues to Regulatory Management as appropriate and maintain open dialog
Assists Regulatory Operations Team to evaluate changes in health authority requirements for eCTD and SPL submissions and implements changes to workflow processes
Preparation of SOPs, working instructions and training material per department process and systems as needed
Other functional duties as required by management
2 - 4 years regulatory or related experience in the pharmaceutical industry strongly preferred

Associate, Regulatory Affairs Resume Examples & Samples

Compiles and reviews ANDAs, Amendments, Supplements, Annual Reports, etc. for FDA submissions
Leads multiple projects, selects methods and provides technical direction to lower-level Associates in the area of regulatory affairs
Designs and develops programs, processes and systems used to ensure accuracy and completeness of regulatory submissions, filings and tracking methods. Develops and analyzes alternative solutions
Ensures policies and practices are reviewed and revised as needed
Works independently. Interfaces with all levels of management negotiating and influencing to build consensus. Presents programs internally and externally. Work is focused on operational plans in support of strategic goals
This position has no supervisory responsibility. This position may have indirect supervisory and/or leadership responsibilities

Senior Associate, Regulatory Affairs Brazil Resume Examples & Samples

Responsible for preparing regulatory submissions which require cross-function interactions with internal and external partners (as appropriate) for investigational and commercial products for Brazil in line with local requirements and company policies and procedures
Responsible for product registration submissions for assigned products, which may include routine submissions (e.g., safety reports, DSUR, PSUR/PBRER, and Registration Renewal, Annual Product Review) as well as post approval variations and labeling updates, as needed
Contribute to preparation and filing of original new registrations or CTA submissions, as required
Provides regulatory support to development and/or revision of product labeling (e.g., local labeling) in accordance with Brazilian requirements and in alignment with company policies and standards
Participate in team meetings whenever required for assigned products; responsible for development of regulatory strategy and presentation of ongoing project updates
Responsible under guidance of immediate manager for own self-development and acquisition of required regulatory skills and knowledge
Initiates or contribute to local process improvements, which have an impact on the working of the Regulatory Affairs function or other departments
Ensure artwork and promotional materials are in compliance with the registered details and local code of practice
Act as pharmacovigilance responsible person deputy, responding for the pharmacovigilance area in the absence of the department manager. Responsible for Safety Activities. The deputy Pharmacovigilance Responsible Person (Deputy PRP) together with the PRP are responsible for
Minimum of a BA/BS degree; an advanced degree is desirable
Minimum 5 years of relevant experience in Regulatory Affairs or related field
Ability to work independently on multiple projects with tight timelines is required. General understanding of regulatory requirements, including ICH requirements and Brazilian requirements for assigned territories
Is recognized as a knowledgeable resource within the department on limited topics
Work is performed under minimal supervision of a Regulatory Affairs professional
Fluent in English, Portuguese native

Associate, Regulatory Affairs, Operations Resume Examples & Samples

2-5 years of experience in pharmaceutical regulatory operations experience required
2-5 years of experience with electronic filing submissions (eCTD) is required. Ability to manipulate large and complex documents required for submissions
2-5 years of experience with document management and electronic publishing systems and tools such as (e.g. Liquent, Extedo, eCTD Express) and document management systems. High level of expertise in Microsoft Suite of products (required), Adobe (required) and ISI Toolbox (preferable)

Associate Regulatory Affairs Resume Examples & Samples

Awareness of regulatory requirements
Monitor applicable regulatory requirements; assure compliance with the company’s and external standards Co-ordinate with global team for documentation
Responding to queries raised by regulatory authorities
Maintain regulatory files in a format consistent with requirements
CTRI registration

Associate Regulatory Affairs Resume Examples & Samples

Archiving documents management if designated as an archivist
Provide the instruction to team for preparing the submission-required documents
Cooperate with Functional Lead and project team to set-up submission timeline and ensure the timeline is achieved as scheduled

Senior Associate, Regulatory Affairs Resume Examples & Samples

Help provide timely and thorough feedback to U.S. operations regarding business initiatives, including but not limited to advertising and promotion, product launch plans, product profile/positioning development to ensure compliance with applicable US regulations and Zoetis expectations
Collaborate with Legal, Corporate Communications, Global Commercial Development and Lifecycle Management, U.S. Operations, BT, and VMRD colleagues to ensure that promotional boundaries and possibilities of product profile messaging are understood within the framework of current USDA/CVB and FDA/CVM interpretation and enforcement
Help provide organizational training and updates across Zoetis regarding actions of USDA/CVB and FDA/CVM that might impact U.S. Operations business opportunities
Help respond to queries and issues from USDA/CVB and FDA/CVM associated with Advertising and Promotional materials
Help provide leadership and advocacy for US Operations for commercialization strategies and competitive activities with trade associations, and government agencies

Associate Regulatory Affairs Resume Examples & Samples

Bachelor’s degree preferred in life sciences, preferably nutrition or biology
At least 2 years of relevant experience; regulatory exposure or some background working in a regulated industry
Experience multitasking in a deadline controlled and highly regulated environment
Ability to communicate effectively in English both verbally and written
Team and customer oriented

Associate Regulatory Affairs Director Resume Examples & Samples

As a TA (therapeutic area) head, lead and manage a team of regulatory professionals
Assist department director for ensuring an appropriate regulatory infrastructure in China to support the growing needs of the business
Be responsible for registration activity for new and existing products in China
Develop regulatory strategies and priorities for relevant TA in line with global, area and China strategies and feed these into the relevant global registration strategies
Make regulatory plans and ensure fast and successful registrations and effective product maintenance, in line with regulatory requirements and China business objectives
Establish and strengthen proactive dialog and communication strategies with regulatory authorities (CFDA, CDE, institute for drug control, and so on) to influence environment and sharp policy
Drive communications and negotiations with regulatory authorities to expedite, secure and optimize regulatory approvals concordant with company goals
Work with regulatory officials and their think-tanks to provide them with scientific materials or information on up-to-date international standards or regulatory trends
Provide regulatory advice to global, area regulatory colleagues and other functional colleagues, in particular, QA, Supply Chain and Commercial
Work with global and area regulatory staff to ensure the regulatory requirements are met and China registration plan is integrated into area and global plan
Work closely and swiftly with brand teams to update regulatory projects, address critical issues and potential solutions
Manage regulatory submissions process, prepare high quality submission documentation to support registration activities
Provided relevant regulatory support for new product launch activities, including re-dressing activities
Scope and implement process and procedures required to maintain all registrations in a cost effective and compliant manner (includes local filing processes and database management)
Manage workload for the team
Manage regulatory budgets for relevant TA
Supervise, train and mentor team members
Create collaborative environment with other functional managers within the Chinese business
Over 15 years regulatory affairs & R&D experience in pharmaceutical or biotech industry, including more than 8 years in the management post
Experience with new chemical entities (NCE), biologics and global trial applications, insight of China local regulatory landscape and in-deep knowledge of regulatory guidelines and requirements
Project management skill
Planning, prioritizing and problem solving adcapabilities
Passionate, accountable, integrity and quality, innovative, focus with a sense of urgency
Experience in leading, developing and retaining a team
Fluent English both oral and written

Associate Regulatory Affairs Director Resume Examples & Samples

8 years in a discipline associated with pharmaceutical development or product oversight; 3 years in regulatory affairs preferred
Proficient technical and regulatory knowledge of the requirements for compliance with GMPs, GLPs, GCPs and including knowledge of regulatory requirements and ICH guidances
A proven track record in leading submissions, interactions with regulatory authorities, approvals and complex programs applicable to the responsibility of the specific role
Roles within a GRA development TA require a proven track record in development and a strong foundation for global responsibilities in a late stage project including communication, alignment and success in association with regulatory strategies for large, complex submissions with a demonstrated ability to effectively influence development team decision making

Associate, Regulatory Affairs Resume Examples & Samples

Interacts effectively with functional business units in order to obtain documentation required for submissions
Evaluates changes to regulatory documents via the change control process and formulates strategies to maintain submission goals
Frequent interaction with Regulatory Agencies
Reviews ANDA labeling documents
Maintains compliance with regulatory requirements for generic drugs for the US market
Maintains Regulatory Databases
Identifies potential issues and resolves routine problems
Prioritizes workload. Receives little supervision for most assignments. Receives general instructions for non-standard analyses and projects
Interfaces to negotiate and exchange information with all levels of management

Senior Associate Regulatory Affairs Resume Examples & Samples

Support regional regulatory filing activities (e.g. core CTA/IMPD development and submission, support for pre-MAA filing, regulatory authority meeting preparations)
Provide and maintain CTA/MA documentation (e.g. variations, substantial amendments, PDCO annual reports) in collaboration with Regional Regulatory Lead
Create and maintain product regulatory history documents through IMR/RISE and appropriately archive all regulatory documents and agency communications
Ensure compliance via timely submissions to regulatory agencies
Collaborate with CROs / partners to support site initiation
Coordinate collection of functional documents in support of regulatory applications
Coordinate QC of regulatory documentation (e.g. briefing packages)
Provide primary authorship to routine regulatory correspondence (e.g. annual reports, investigator packages)
Prepare regulatory packages and cross-reference letters to support investigator initiated studies
Approve drug shipment for Amgen and Investigator Initiated Studies
Complete regulatory forms to support agency communications (e.g. EudraCT)
Provide regulatory support to Commercial, Medical and Clinical departments through cross-functional interactions in brand and therapeutic area teams
Support process improvement initiatives, standards development, and metrics
Assist in template development and maintenance
Respond to specific requests from - and communicate relevant issues to - GRT
Develop Regulatory Position with teams
Actively support regulatory compliance
Support the development and execution of GRT goals
Graduate in related discipline
Broad EU clinical trial application experience is essential
Understanding of drug development process, e.g. clinical trial phases
Strong communication skills - oral and written
Experience in oncology therapeutic area (preferred)

Associate, Regulatory Affairs Resume Examples & Samples

Utilizes multiple regulatory databases to ensure the stringent accuracy and compliance of label data for assigned products, including: Nutrition Facts, Ingredients, Allergy disclaimers, Dietary/health claims, etc
Collaborates with Regulatory and business team members to verify the usage for all certification symbols, in accordance with SOPs, including: Organic, Gluten-free, Non-GMO, Kosher symbols, etc
Partners with Research and Development (R&D) and Quality Assurance to verify net contents statement and slack fill requirements per FPLA and Review product and packaging accuracy of consumer safety information, such as (i.e. storage/temperature requirements, choking hazards, expiration dates, etc
Collaborates with Marketing and R&D on New Product Development commercialization process to document and provide input on product benefits for achieving compliance and competitive advantage
Updates and manages all domestic/international technical product information within internal database and provides documentation, as needed
Reviews final packaging artwork to submit to Marketing, Purchasing database managers, and Consumer Relations, as directed
Assists Consumer Response personnel in responding to consumer inquiries
Corresponds with Marketing on package change notification for updating product reformulations
Minimum 1-3 years experience in a technical function, preferably in regulatory compliance in the CPG industry
Working knowledge of FDA and USDA regulations, including National Organic Program
Experience with Food GMP’s, SOP’s, HACCP/Food Safety and Environmental guidelines
Export experience is a plus
Excellent organizational skills, ability to prioritize multiple priorities and strong attention to detail
Computer skills including MS Office programs such as Outlook, Word, Excel PowerPoint
Strong interpersonal skills and ability to communicate (verbal/writing) effectively
Self-motivated and strong analytical / problem solving skills
Ability to collaborate at all levels of the organization and across other functional areas
Ability to maintain a high level of confidentiality
Preferred knowledge of the Consumer Product Goods Industry.EEO/AA/M/F/Veteran/Disabled

Senior Associate, Regulatory Affairs Resume Examples & Samples

Preparing and writing ANDAs and other approval materials, including but not limited to PAS, CBEs, and annual reports, for submission to the FDA
Developing professional relationships with FDA personnel to help ensure organization adheres to laws and regulations, and receives proper guidance
Creating and maintaining databases, and updating tracking systems related to FDA submissions
Bachelor’s Degree or higher applicable to the pharmaceutical field, preferably within Regulatory Affairs
CMC Regulatory Affairs and ANDA experience
Must have strong working knowledge of Microsoft Office and eCTD publishing tool

Senior Associate Regulatory Affairs CMC Resume Examples & Samples

Bachelor’s degree and significant Regulatory CMC experience
Broad experience of pharmaceutical/biotechnology or medical device industry
Specialist knowledge of Regulatory Affairs
Strong communication skills - oral and written Organizational skills
Understanding of drug development process
CMC- specific regulatory knowledge & experience
Ability to develop solutions to technical and organizational issues in order to improve performance and productivity
Strong computer skills, including word processing, database document repository and project management software
Strong team player with a commitment to customer service

Senior Associate, Regulatory Affairs Resume Examples & Samples

Participate in and contribute to project bids, including client presentations
Support the feasibility evaluation process from Regulatory Point of View
Regulatory related submission and coordination, including initial submission, supplementary submission, amendment application and etc
Highlight common issues and address these with the team as a training need and strategically guide/assist project team to resolve the issues

Associate, Regulatory Affairs CMC Resume Examples & Samples

At least 2 years of experience in Regulatory Affairs or a related function (such as Quality or Process Development) in a global pharmaceutical and/or biotechnology company, preferably with exposure to biologic products
Outstanding interpersonal and communication (written and verbal) skills is required
Strong writing and editing skills for technical documentation
Project management skills are a plus

Senior Associate, Regulatory Affairs Resume Examples & Samples

Oversee planning, preparation, and submission of the CMC sections of marketing and clinical trial applications globally. Ensure that the sections are complete, well-written, and meet all relevant requirements
Develop excellent relationships with internal functional groups, contract manufacturing organizations, and partners
Assess proposed manufacturing changes and provide strategic regulatory guidance as to how to best implement changes globally
Provide regulatory advice to technical operations departments based on knowledge of current requirements
Manage interactions with FDA or other regulatory authorities for assigned projects
At least 3 years of experience in Regulatory Affairs or a related discipline in the pharmaceutical or biotechnology industry (preferably with exposure to the development phase of the product lifecycle)
Experience in filing post-marketing supplements, INDs, CTAs for pharmaceutical or biologic products in the US and/or Europe is required
Thorough understanding of relevant drug development regulations and guidelines
Outstanding interpersonal and communication (written and verbal) skills; proficient with computer and standard software programs

Senior Associate, Regulatory Affairs Resume Examples & Samples

Greenlist EC score creation and maintenance: edit, and maintain packaging component Greenlist EC scores on all new or changed packaging components used by SCJ
Facilitate the transfer of this information to the PDC Group for generation of packaging documents and material master links in PLM
Data Integrity, Audits, and Assessments: Review packaging component EC scores and check supplier data for consistency and accuracy; provide data quality checks once EC scores are automated; and provide support for packaging related regulatory mandated reporting
Data Remediation: Take corrective steps as required from data reviews and audits; work with suppliers and business partners to obtain incomplete or missing packaging component data necessary to calculate Greenlist EC scores
Analysis: Recommend packaging components for elimination based on the SCJ RUM List, assist in the creation and/or continuous improvement of Global Environmental Safety’s processes and procedures
Data Protection: Interface with Law Department to secure Confidential Disclosure Agreements (CDAs), uphold confidential information in all practices

Associate, Regulatory Affairs Resume Examples & Samples

Coordinate the clin-nonclin preparation and submission of domestic and international regulatory submissions, including the following
Minimum 2 years experience in Regulatory or equivalent training and experience in related function such as Clinical or Nonclinical; preferred 2 years experience in Regulatory
Proficiency with computer and standard software programs is required

Associate Regulatory Affairs Mgr-licensing Resume Examples & Samples

Under limited supervision, provides regulatory support to ensure Medline continuously complies with state and federal requirements pertaining to the distribution of prescription drugs to our Customers
Facilitates communication with internal & external business partners to assess & strategize to meet licensure requirements
Analyze current business processes for improvement as well as develop/implement new processes and procedures to maintain regulatory compliance
Develop and mentor staff through on-boarding, open communication, training and development opportunities, and performance management processes
Oversee the maintenance of licensure data including capturing, validation & recordkeeping to support compliance of federal and state requirements related to the distribution of prescription drugs and medical devices
Proactively communicate relevant requirements of state and federal regulations to internal or external customers to ensure that Medline is operating within compliance
Lead prime vendor/group implementations with customers and business partners to ensure successful transition strategy
Provide day-to-day direction and oversight to RA staff

Senior Associate, Regulatory Affairs Resume Examples & Samples

5) Maintain regulatory files in a format consistent with requirements
7) Support regulatory activities relating to specific portfolio of products/projects (product owner)
8) Maintain and update existing regulatory authorizations
1) Scientific knowledge
2) Written and Verbal communication skills
3) Knowledge of regulations
5) Technical system skills (e.g. word processing, spreadsheets, databases, online research)
7) Ability to identify compliance risks and escalate when necessary
8) Bachelor's degree or country equivalent in pharmacy or related scientific discipline with a minimum of 2 years regulatory or equivalent experience within a pharmaceutical company, CRO, or similar organization
9) 9) Knowledge of hardware and/or software helpful
10) Higher degree/PhD will be an advantage

Associate Regulatory Affairs Director Resume Examples & Samples

Advanced degree in a Science discipline
Minimum 10 years’ experience in Regulatory Affairs within the pharmaceutical industry with minimum of 5 years regulatory affairs management experience. A considerable amount of this experience should have been gained in a senior role in the area relevant to their position
Demonstrated experience designing and implementing regulatory product strategy, interfacing with local and/or corresponding international regulatory bodies, including negotiation of pharmaceutical product approvals & lifecycle maintenance, resolution of issues and influencing/lobbying directly and through other external groups (e.g. trade associations)
Demonstrated understanding of the healthcare environment and knowledge of current competitive, commercial or political situations and their impact on regulatory strategies in China would be highly desirable
Demonstrated experience operating in a highly regulated environment. Proven application of analytical skills in a regulatory environment
Excellent verbal and written communication and presentation skills with the ability to speak and write clearly and convincingly in English & Chinese, tailoring communication methods to customer’s requirements
Ability to influence at all levels of the company
Ability to work independently as required using sound judgment
Demonstrated ability to form, lead and manage cross-functional, cross-business teams
Demonstrated project management skills and the ability to prioritize, plan & evaluate deliverables to established strategic goals
Demonstrated knowledge & experience conducting scientific, regulatory, legal, or business research
Must be willing to travel as needed for key activities

Senior Associate Regulatory Affairs Resume Examples & Samples

Provides regulatory advice and support to assigned products/teams. Identifies and communicates registration needs and strategies. Maintains awareness of applicable regulations
Plans and organizes registration packages for drug products. Prepares registration packages in line with local regulatory requirements and guidelines
With oversight, serves as a liaison with regulatory agencies pertaining to assigned products. Assists in the preparation of agency meeting packages and strategies for agency meetings
Evaluates manufacturing and labeling changes for regulatory impact with guidance. Accurately describes these changes for ease of regulatory agency review
Represents Global Regulatory Affairs at research and development meetings and presents agreed upon regulatory positions. May serve as a lead regulatory representative to an assigned product or project team
Work on special projects as they arise
Able to follow scientific arguments
Developing negotiating skills
Developing understanding of business needs
Bachelor’s Degree is required: Pharmacy, Biology, Chemistry, Pharmacology, Engineering, or related subject
Three to five years of experience in Regulatory Affairs, Research, Development or related area
Must pass pre-employment drug screen and background check

Senior Associate, Regulatory Affairs Resume Examples & Samples

Directly accountable for regulatory compliance for North America and for support of additional countries as assigned (Local / Regional / Global)
Understands and applies relevant GSARA processes
Identify and interpret domestic and international applicable laws, regulations and related performance standards that apply to chemicals, their use in Company’s products, and their distribution, and help develop, and implement processes and procedures to facilitate and promote global compliance
Serve as a Subject matter expert for US regulations, such as OSHA or CPSC
Understand CPSC, FHSA, and OSHA label requirements for US sold goods
Maintain awareness of emerging issues and changing regulatory landscapes, make recommendations on portfolio management for products under accountability
Maintains company databases and compliance related IT tools; PLM, SharePoint, etc
Responds to requests from project teams to provide critical input into regulatory needs for product launches
Continuously evaluates the regulatory climate of assigned countries, identifies potential issues which may arise, work to favorably impact the outcome of emerging or existing issues
Author required reports/submissions that are mandated by local authorities to ensure uninterrupted operation
Be able to manage local consultants that would help in specialized regulatory research
Generate regulatory documents to fit local and global specifications (e.g., SDS etc.)
Analyze and report to management change in regulations or impending new regulations
When appropriate, serve on government or industry task forces as a representative of the company in partnership with Government Relations. Seek to favorably impact regulatory requirements which will benefit the SCJ business
2 plus years work experience in compliance-related field with progressively broadening responsibilities
Strong technical background in chemistry, chemical engineering, life sciences or related discipline. A four-year scientific or engineering college degree is required
Experience in multi-national consumer product, chemical, pharmaceutical and/or agricultural companies, or government agency or consulting firm working with such companies
Commanding knowledge of current global, federal and state regulations, including chemical inventories and product compliance
Computer literate; effectively utilize web-based and internal databases and systems such as SAP PLM, third-party electronic regulatory data sources such as ChemAdvisor’s LOLI, and Microsoft Office software
Proven situational leadership skills and demonstrated experience in influencing internal stakeholders as well as forging strong relationships with colleagues
Demonstrated ability to participate in multi-functional teams, ability to summarize and communicate regulatory issues to colleagues outside of regulatory functions
Excellent listening, written and verbal communication and interpersonal skills
Detail-orientation. Effective prioritization, project management, and critical thinking skills
Problem solving skills with the ability to bring project to final conclusion
Self-directed with a “can do” attitude and willingness to drive change that may not be inspired by him/her and is being asked of him/her

Senior Associate, Regulatory Affairs Strategy Resume Examples & Samples

Execute on the defined regulatory operating plan, and provide feedback for continuous improvement
Prepare and/or coordinate region/country specific regulatory documents for submission
Actively participate on GRA sub-team and represent GRA on cross-functional teams, such as study execution teams
Support region-specific Health Authority interactions
Assist in developing and coordinating regulatory timelines for assigned deliverables, working closely with the Regional Regulatory Leads, Global Regulatory Lead and other key stakeholders
Ensure compliance of regulatory submissions with current regulations and guidance
Contribute to the continuous improvement of existing department processes and strategies
Minimum of Bachelors degree in relevant scientific discipline, higher degree desirable
Ph.D. (or equivalent degree) and 1-2 years of relevant work experience, or
M.S. (or equivalent degree) and 2-3 years of relevant work experience, or
B.S. (or equivalent degree) and 3+ years of relevant work experience
Knowledge of regulatory procedures and legislation for drug development, product registration, line extension and license maintenance – preferably from at least both US and EU
Ability to effectively collaborate with internal and cross functional colleagues to achieve business objectives
Strong written and oral communication, listening, and non-verbal communication skills
Able to work effectively in a matrix environment
Capable of strategic thinking
Actively pursues innovation and excellence

Senior Associate Regulatory Affairs Resume Examples & Samples

A minimum of a Bachelor’s Degree is required. An advanced degree (Masters, PhD, PharmD, etc.) is preferred
A minimum of 3 years direct or indirect experience in Regulatory Affairs is required
Experience with clinical efficacy programs, INDs, NDAs/sNDAs, monograph products and knowledge of the Rx-to-OTC switch process and ANDAs is all required
A minimum of 15% travel is required including to local sites in the area, as well as other locations based upon business needs

Associate, Regulatory Affairs Resume Examples & Samples

Supports senior Regulatory personnel in preparing new product marketing submission for the FDA (510k, PMA)
Supports international Regulatory requests
Sends out notifications of change to the Notified Body as required
Supports divisional and corporate litigation requests as needed
Bachelors Degree in Life or Engineering Science, Business, or equivalency
Good writing and strong organizational skills required
Demonstrated communication and human relation skills
Ability to review, collate and summarize scientific and technical data
Excellent problem solving and analytical skills
Ability to work well within cross-functional teams

Senior Associate Regulatory Affairs Submission Management Resume Examples & Samples

With manager support, manages/provides operational oversight to ensure timely, high quality regulatory submissions. Participates in the development of project plans using established templates. Plans and negotiates publishing timelines with the teams
Effectively manages multiple projects and competing priorities
Acts as primary Submission Operations interface with project teams providing guidance and communication of established submission processes and standards
Plans and conducts submission team meetings
Communicates effectively verbally and in writing with diverse audiences and across various levels within the organization
Anticipates obstacles and develops solutions within the team
Participates in the development of optimal business processes and practices within the department to ensure high levels of customer support and to achieve high quality submissions. Identifies opportunities for efficiencies, business process improvements and cost reduction
Demonstrates team leadership skills and ability to influence without direct authority. Builds and maintains positive relationships internally and externally
Position accountability/scope includes some supervision of projects and assistance with priority setting required. Receives project assignments from manager but has responsibility for managing own projects. Reviews project progress with manager on a regular basis with direction provided on follow-up
Identifies opportunities for process improvements or cost savings. May participate on internal project teams to update business processes. Provides support in on-boarding new staff
High School diploma or equivalent and 4 years industry related experience
5 years pharmaceutical or industry related experience
Experience working in a complex and matrix environment
Strong communication skills both oral and written

Senior Associate, Regulatory Affairs, CMC Resume Examples & Samples

At least 5 years of experience in Regulatory Affairs or a related function such as Quality, Process Development in a global pharmaceutical and/or Biotechnology Company (preferably with exposure to biologic products)
Thorough understanding of relevant drug development regulations and guidelines (i.e., FDA regulations and ICH guidelines) as well as an understanding of cGMPs
Effective task planning and coordination abilities

Senior Associate, Regulatory Affairs Resume Examples & Samples

Provide timely and thorough feedback to U.S. operations regarding business initiatives, including but not limited to advertising and promotion, product launch plans, product profile/positioning development to ensure compliance with applicable US regulations and Zoetis expectations
Provide organizational training and updates across Zoetis regarding actions of USDA/CVB and FDA/CVM that might impact U.S. Operations business opportunities
Respond to queries and issues from USDA/CVB and FDA/CVM associated with Advertising and Promotional materials
Provide leadership and advocacy for US Operations for commercialization strategies and competitive activities with trade associations, and government agencies

Operations Associate, Regulatory Affairs Resume Examples & Samples

Assembles, prepares and submits original registrations, amendments, supplements, variations, maintenance reports and other documents to regulatory agencies in line with local regulatory requirements and guidelines.This activity includes local and regional submissions as applicable, such as Structured Product Labelling (FDA) and submissions to Health Canada
Understands and complies with agency guidelines relating to regulatory submissions for both paper and electronic submissions and to ensure that documents are formatted in a way to meet these requirements
Implements and maintains internal systems, processes and documentation to ensure the accurate compilation of new license applications, involving the maintenance of document templates, updating internal procedures following updates to agency guidelines
Provides guidance and training to other members of the Regulatory Operations Group relating to regulatory submissions
Completes product/project specific tasks to ensure successful regulatory submission, including the following (this list is not exhaustive)
Basic knowledge of regional agency guidance and regulations as related to regulatory affairs
Experience in regulatory operations, and dossier authoring and publishing, in both paper and electronic format
Experience with implementation of process improvements
Logical and accurate approach to work with excellent attention to detail
Ability to work in an organized manner and with minimum supervision
Strong technical computer skills
Strong knowledge of Microsoft Word and Adobe Acrobat
Basic knowledge of Microsoft Excel
Bachelor’s Degree in pharmacy, biology, chemistry, pharmacology, engineering or related field
Two to three years’ experience in quality assurance/compliance, regulatory affairs or research and development or related area preferred
Must pass pre-employment drug screen and background check