Associate, Regulatory Resume Samples

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E Pfannerstill

Elinore

Pfannerstill

50160 Alfredo Plaza

Boston

+1 (555) 434 4909

50160 Alfredo Plaza

Boston

Phone

p +1 (555) 434 4909

Experience Experience

Phoenix, AZ

Associate Regulatory Program Manager

Phoenix, AZ

Stark, Hayes and Funk

Phoenix, AZ

Associate Regulatory Program Manager

Supports management of relevant project budgets to ensure compliance with agreed parameters and provides routine and ad hoc budget reporting and other updates
Supports Regulatory Program Management Program Directors in providing internal teams with direction on regulatory authority interactions
As assigned, performs literature searches, prepares special reports and assembles documentation to support project teams
Participates in site, regional and/or global PDR Program Management departmental meetings
Obtains and applies in-depth knowledge of Roche and regulatory guidelines, procedures and best practices
Stays abreast of therapeutic area product development and other related business strategies and plans
Helps manage project plans and timelines for assigned projects

Los Angeles, CA

Senior Associate, Regulatory Consulting

Los Angeles, CA

Crona, Larkin and Beier

Los Angeles, CA

Senior Associate, Regulatory Consulting

Collating and manipulate data, visualising trends and patterns in performance
Prepare pitch documents and proposals for potential work
Create smart and cost-effective ways of working, whether focused on process or control improvement, behavioural change or the use of enabling technology
Deliver on a wide range of engagements, including working in the following areas
Participate in regulatory due diligence work on behalf of firms preparing for sale, and on client acquisition targets
Strengthen operating and organisation models, so that they are more closely aligned to strategies whilst removing gaps and friction from the interactions of core services
Create and communicate clear business cases for change, building buy-in and momentum as a pre-cursor for change

present

Dallas, TX

Associate Regulatory Program Director

Dallas, TX

Miller-Lowe

present

Dallas, TX

Associate Regulatory Program Director

present

Job level: Individual contributor
Network: Site and Global Experts, PTR International Operations,
Awareness of current health authority trends and focus and implementation into global submissions
Provide support for the implementation of global regulatory strategies defined by the Technical Regulatory Lead associated with the life-cycle of the assigned product(s) including
Generation of global post-approval submissions
Responsible to manage open TRICs for assigned products and regions
Product change assessments. Perform change assessments within the agreed SLA with quality. Escalate potential issues to product TRL and line manager

Education Education

Bachelor’s Degree in Life Sciences

Kean University

Bachelor’s Degree in Life Sciences

Skills Skills

Excellent negotiation and communication skills with ability to challenge
Excellent interpersonal skills and strong team player
Proven ability to work through others to deliver results to the appropriate quality and timeline metrics on complex projects and programs
In-depth knowledge and ability to apply Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines and applicable regulatory guidelines
Excellent leadership skills, with ability to motivate, coach and mentor
Excellent regulatory and/or technical writing skills
Demonstrated proficiency in using systems and technology to achieve work objectives
Thorough understanding of regulated clinical trial environment and in depth knowledge of drug development process
Excellent organizational and planning skills
Proven ability to exercise independent judgment taking calculated risks when making decisions

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15 Associate, Regulatory resume templates

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Associate Regulatory Project Management Team-product & Platform Team-private Bank-geneva Resume Examples & Samples

Experience in Private Banking, Asset Management or Investment Banking industry with a proven track record of delivering change within a large, highly complex, cross-functional environment
Significant project and change management experience
A broad understanding of securities, instruments, structured products, portfolio management techniques, investment processes, and investment management products
Minimum of a Bachelor's degree

Senior Associate Regulatory Solutions Resume Examples & Samples

Be responsible for regulatory submissions and maintain appropriate information for progress reporting to head of department and senior management
Communicate product information and reporting progress clearly and confidently to team members, management, peers and clients
Relevant good quality experience in the finance industry. Such as working in; investment banking, asset management or financial services
Ability to find creative solutions to complex analytical problems
Experience of using Cognos or SQL is preferred

Senior Associate, Regulatory Supervision Resume Examples & Samples

Ability to multitask and work independently
Excellent written and oral skills with attention to detail
Proven ability to learn quickly and take on new tasks
Able to easily adapt to a fast paced, changing environment
Knowledge of Microsoft Office, Word, Excel and Power Point
Strong knowledge and understanding of compliance requirements and regulations
Ability to work with a diverse group of people including field and home office associates

Associate, Regulatory Solutions Resume Examples & Samples

Responsible for the identification, assessment and escalation of key regulatory changes affecting I&TS and its clients within specific regions by following the steps of the GRS' Regulatory Change Lifecycle
5-10 years progressive financial industry experience
Post-secondary education including Masters degree or multiple Bachelor degrees preferably in Mathematics, Science, Finance, Economics and/or Law
Prior experience in the implementation of complex and effective regulatory solutions and projects
Strong project management training and understanding of PMF
Understanding / knowledge of capital markets, funds and custody markets, and banking sector as well as industry regulations

Associate, Regulatory Strategies Group Resume Examples & Samples

Three to five years of work experience, with at least two years in an associate-level or project management role
Bachelor’s degree in environmental studies, economics, public policy or other applicable field required; Master’s degree in a relevant field strongly preferred
Experience in client services or a consulting firm; experience with air quality, climate, transportation, Western water issues, and/or energy a plus
Excellent interpersonal skills, including the ability to effectively communicate with senior management
Professionalism, poise, and the ability to work as part of a team
Outstanding research, analytical, writing, and editing skills
An insightful, curious, pragmatic, and strategic mind
Passion for environmental issues
Ability to handle sensitive matters with discretion and interact with a diverse array of people
Ability to work under pressure, prioritize, and manage multiple, often competing tasks
Willingness to travel, as requested

Senior Associate Regulatory Labeling Resume Examples & Samples

J-NDA filing and registration skills of medicines in Japan
Knowledge for local regulations and requirements for labeling and package insert
Negotiation skill for label and package insert with Japanese Health Authorities
Negotiation skill for label and package insert with Global Labeling Working Team
Working in matrix environments in Japan and global teams as the One Team
English and Japanese conversation, read, and writing
IT skills: Microsoft Outlook/ Word/ Excel/ Power Point
Knowledge for labeling and package insert preparations, approvals, and maintenance in Japan (more preferred biologics and/or combination product experiences)
Negotiation for content of label and package insert with PMDA

Senior Associate Regulatory Submission Information Resume Examples & Samples

Awareness/experience with XEVMPD (eXtended Eudravigilance Medicinal Product Dictionary)
Experience using electronic document management systems, regulatory publishing systems and/or regulatory tracking database
Experience in Regulatory Affairs or Regulatory Operations within the pharmaceutical industry
Experience providing on-time and high-quality support for litigation activities, due diligences, responses to requests for regulatory information, audit and inspections, and application transfer and acquisitions
Experience supporting new/harmonized regulatory information management systems/tools, standards, and process efficiencies
Working knowledge of all regulatory information management tools and document management systems
Working knowledge of eCTD

Associate, Regulatory Supervision Resume Examples & Samples

Provide self-supervising oversight on regulation matters for all U.S. sales and trading desks
Perform various monitoring activities and trade surveillance including: OATS, ACT, TRACE
Assist with trade surveillance for multi-asset classes where applicable (equities, listed/OTC equity derivatives, fixed income, treasury, money markets, repo)
Primary business contact responsible for assisting Compliance in preparing detailed responses to address regulatory inquiries on trading related matters
Maintain and enhance the documentation of internal policies and written supervisory procedures to comply with trading regulations (SEC/FINRA and other)
Create and implement procedures that clearly show “evidence of review” and follow-up that will be satisfactory to both the SEC and any Self-Regulatory Organization
Conduct and document internal reviews of trading activity
Proactively provide updates and advice on regulatory matters on a timely basis
Ensure that employees responsible for trading securities are appropriately registered
Escalate significant issues or material incidents of non-compliance to the relevant U.S. line of business head, senior Compliance officer and trading management promptly for resolution including recommendations for corrective action
Provide timely advice and guidance to trading floor personnel and business management on transactional issues
Monitor new and changing regulatory requirements on a timely basis and assess their potential impact
Participate in appropriate industry committees and working groups
Work on special projects as assigned from time to time

Associate Regulatory & Start Up Director Resume Examples & Samples

Oversee the execution of Start Up (including pre-award/bid defense activities) and/or Maintenance for assigned projects in accordance with the agreed RSU strategy, adhering to project timelines
Develop, implement and maintain the RSU Management Plan according to the Scope of Work and Project Plan, within the agreed project strategy, resolving project related and cross-functional issues where required
Ensure collaboration across RSU, including communication with regions and countries, to successfully deliver the agreed project scope in compliance with the RSU Management Plan; coaching members of the team to ensure timely delivery of projects
Create and/or review technical and administrative documentation to support business development and enable study initiation and maintenance, as required
Provide specialist regulatory and technical scientific support to facilitate efficient business development, initiation and maintenance of clinical trials, whilst enabling compliance with regulatory requirements
Provide overall guidance and oversight of multi-regional and multi-protocol programs during initial start-up and maintenance phase as an integral member of the study management team
Determine regulatory strategy/expectations and parameters for submissions and all necessary authorizations; identify regulatory complexity and challenges and offer creative and practical solutions to support the bid process and subsequent execution of the RSU plan
Assess and review the regulatory landscape and contribute to the collection, interpretation, analysis and dissemination of accurate regulatory intelligence to support assigned studies and wider company, as required
Oversee and execute operational strategy/ expectations for maintenance of clinical study approvals, authorizations and review/ negotiation of contracts and essential documents
Work with Quality Management to ensure appropriate quality standards for the duration of Start Up (or Maintenance, as applicable)
Mentor and coach colleagues as required and provide technical guidance both within and outside the project
Ensure accurate completion and maintenance of internal systems (with emphasis on CTMS), databases, tracking tools, timelines and project plans with project specific information
May take a lead role in developing long standing relationships with preferred Quintiles customers and initiate cross functional issue resolution to meet customer needs adapting Quintiles processes
Deliver presentations/training to clients, colleagues and professional bodies, as required
Serve as liaison for non-specific projects for key customers
Excellent negotiation and communication skills with ability to challenge
Excellent interpersonal skills and strong team player
Proven ability to work through others to deliver results to the appropriate quality and timeline metrics on complex projects and programs
Thorough understanding of regulated clinical trial environment and in depth knowledge of drug development process
Demonstrated proficiency in using systems and technology to achieve work objectives
Excellent regulatory and/or technical writing skills
In-depth knowledge and ability to apply Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines and applicable regulatory guidelines
Excellent leadership skills, with ability to motivate, coach and mentor
Excellent organizational and planning skills
Proven ability to exercise independent judgment taking calculated risks when making decisions
Excellent presentation skills
Proven ability to establish and maintain effective working relationships with co-workers, managers and sponsors
Strong financial acumen
Proven ability to work on multiple projects balancing competing priorities

Associate Regulatory Program Manager Resume Examples & Samples

Intact & Cross-Functional Teams
Participates in site, regional and/or global PDR Program Management departmental meetings
As assigned or otherwise needed, assists relevant Regulatory Program Directors with their interactions, communications and planning with various other teams, dependent upon assigned projects and the associated development phase, such as early development core teams, global development teams and lifecycle teams. Helps Regulatory Program Directors coordinate cross-functional PDR contributions to product development projects and other related activities
Supports on one or more regional projects at any one point in time
Supports Regulatory Program Directors in identifying and aligning cross-functional regulatory resources necessary to execute the regulatory strategy for each project or related assignment
Supports Regulatory Program Directors and others in scheduling and preparing for meetings, teleconferences and other interactions/communications with regulatory authorities. Establishes effective working relationships internally and externally with regulatory authorities
Supports Regulatory Program Management Program Directors in providing internal teams with direction on regulatory authority interactions
Helps manage project plans and timelines for assigned projects
As assigned, performs literature searches, prepares special reports and assembles documentation to support project teams
Supports effective, best-practice maintenance of various clinical and non-clinical regulatory documents
Participates in and supports development of regulatory risk management and contingency plans. Develops associated communication plans for Regulatory Program Management Program Directors and their internal distribution
As requested or otherwise appropriate, supports Regulatory Program Management Program Directors in providing regulatory due diligence assessments in cooperation with other internal groups
Completes other routine and ad hoc analysis and reporting. Responsible to keep all internal customers, partners and stakeholders abreast of progress and interim updates. Does so by following prescribed departmental procedures, practices and protocols and by using standardized reporting and communications tools/templates and other resources
May participate in other special projects, as and when assigned, or otherwise requested

Associate Regulatory Opererations Specialist Resume Examples & Samples

Must be able to stand sit/walk for extended periods of time. The employee is also required to interact with a computer, and communicate with peers and co-workers
Light lifting
Extended periods of time doing computer-based work

Associate Regulatory Fuels Analyst Resume Examples & Samples

Provides analysis to support the team in identifying, evaluating, and modeling external data (EIA, EPA, CARB, etc.), budget data, optimization opportunities, and monthly operating plan to ensure compliance with government regulatory fuels requirements and helps facilitate decision-making
Researches regulatory fuels requirements in order to assist others in interpretation that support the organizations goals and objectives. Responsible for reviewing and updating processes and procedures with any changes to the regulatory fuels requirements
Provides support with presentation preparation by maintaining monthly balance for ownership of compliance instruments for RFS, LCFS, AB32, CFP
Analyzes economic value of project or business opportunities

Senior Associate, Regulatory Informatics Resume Examples & Samples

Business Analysis and Project Management
Advanced computer skills, especially in MS Office, Adobe Acrobat, and electronic document management systems (EDMS) experience with scanners and copiers, able to multi-task and set priorities, pay close attention to details, work in team environment
Computer skills in the Liquent InSight platforms , Acrobat plug-ins such as ISI Toolbox, and other Regulatory Operations systems with understanding of submissions processes and electronic standards (eCTD, RPS, etc.)
Knowledge of Computer Systems Validation processes, and ability to apply BioMarin Systems Development Lifecycle to Regulatory Information Management projects
Uses professional concepts and company’s policies and procedures to solve a wide range of moderate problems in imaginative and practical ways
Works on problems of diverse scope in which analysis of data requires evaluation of identifiable factors. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions
May determine methods and procedures on new assignments

Associate / Regulatory & Start Resume Examples & Samples

Perform Regulatory, Start-up and Maintenance activities according to applicable regulations, SOPs and work instructions
� Prepare site regulatory and contractual,reviewing for completeness and accuracy
� Inform team members of completion of regulatory and contractual documents for individual sites
� Review, prepare and negotiate site contracts and budgets with sites as directed
� Distribute completed documents to sites and internal project team members
� Support the updating and maintenance of internal systems, databases, tracking tools, timelines and project plans with accurate and complete project specific information
� Review, track and follow up the progress, the approval and execution of documents, including contracts, regulatory ethics, ICF and IP Release documents,by coordinating between RSU Team Lead, Clinical Operations, Feasibility,Site Identification, Project Management and CST
� Participate in feasibility and/or site identification activities
� Understanding of regulated clinical trial environment and knowledge of drug development process
� Strong verbal and written communication skills including good command of the English language
� Ability to work independently and to effectively prioritize tasks
� Good organisational and planning skills
� Ability to establish and maintain effective working relationships
� Knowledge of applicable regulatory requirements, SOPs and company’s Corporate Standards

Associate Regulatory Program Manager Technical Regulatory Bio Development Resume Examples & Samples

Utilizes practical understanding of relevant HA guidelines, Roche GSPs and expected submission requirements and content to manage the scope of activities and submissions assigned
Actively consults line management, SMEs and approved internal Regulatory Standards and information databases to ensure strong understanding of historical precedent for topics assigned
Knowledgeable in technical regulatory department processes required for scope of assignments (assigned by Line Manager)
Has sufficient technical understanding of process and product development processes to complete assignment within assigned scope
Executes work priorities and timelines with consultation of Line Manager and TRL

Associate Regulatory Submissions Manager Resume Examples & Samples

Provide centralized expert support and guidance to all Regulatory functions (US RA liaisons, GRS, GRA/PMs, CMC liaisons, CMC liaisons) cross-functional document authors, support staff, and publishers on the creation, preparation, tracking, publishing, QC/QA, filing Global submissions, including training, troubleshooting and responding to “help-desk”-type calls directed at the submissions department
Institute QA/QC policies and procedures for Global electronic submissions and associated workflow processes
Capture corporate knowledge regarding Global submission standards and best practices across drug projects and transfers knowledge across project teams and disciplines (via process documentation, standards development, submission document template development, technical training and process training)
Develop, implement and maintain a comprehensive training curriculum associated with all aspects of the e-submission process
Act as the Global Submissions functional area expert and lead trainer
Provide training of new and temporary Global Submissions staff as well as global project team members (cross-functional document authors)
Work with document authors across all disciplines to develop and maintain a comprehensive set of e-submission document templates
Work with the Information Systems Groups to maintain state-of-the-art e-submission authoring tools (e.g. Adobe Acrobat, MSWord, Endnotes, DDS, Compose, EZsubs, ISI Toolbox, etc.) techniques (e.g. table captioning, document styles, cross-referencing, etc.)
Monitor evolving agency regulations and assures Bayer submissions comply with all document/file formats and structures
Compile and publish documents/dossiers of various dossier types, for both new product marketing applications and/or marketed product maintenance packages, including both domestic and international submission types (e.g. IND, NDA/sNDA, MAA, CTD/eCTD, CTA/IMPD, PSUR, Agency Meeting Briefing Packages, Major Variations, Product Renewal, CMC amendment, IND/NDA annual report, information amendment, DMF update, etc)
Minimum of a high school diploma with 14+ years of progressively increasing responsibilities and relevant experience or a Bachelor degree with 6+ years of progressively increasing responsibilities and relevant experience or a Master degree with 5+ years of progressively increasing responsibilities and relevant experience
Relevant experience may be met via a combination of electronic data/document management, project management, computer systems or publishing software support, electronic document publishing and/or regulatory affairs
Knowledge of drug development process and relevant SOPs is required along with an understanding of federal regulations, international standards (e.g. ICH, IBH), and regulatory guidances as they pertain to the development and filing of e-submissons and ability to interpret implications of these regulations, apply them to daily operations and to respond appropriately to questions from peers and cross functional professional staff
Working knowledge of word processing, document management, and desktop publishing software packages, including hands-on knowledge of various document types, authoring tools and file formats (such as MS office templates, PDF files, SAS program/transport files, XML program code, etc.)
Previous experience with a document management or electronic publishing tools (such as PDF Fusion, EZsubs, Core Dossier, ISI Toolbox, Docubridge etc.)
Working knowledge of databases and data structures (such as Lotus Notes databases, Oracle IMPACT, MS Access, SAS, etc.)
Excellent verbal and written communication skills plus interpersonal skills to interact with various levels of international document authors and support staff across all disciplines
Solid project management skills, tools and techniques and the ability to apply these directly to managing Regulatory submission projects
Self-motivation, sense of urgency, attention to detail, sound judgement, and good follow-through are also essential
Multi-cultural sensitivity gained from some direct international experience

Senior Associate Regulatory Labeling Resume Examples & Samples

Knowledge for local regulations and requirements for J-PI, IFU and package label
Japanese native level
IT skills: Microsoft Outlook/ Word/ Excel/Power Point
Knowledge for packaging label, IFU and J-PI preparations
Knowledge for package label, IFU and J-PI update
Reasonable English writing and reading capability

Senior Associate, Regulatory Supervision Resume Examples & Samples

The successful candidate should have a working knowledge and understanding of compliance requirements and regulations, basic knowledge of insurance and investment products, basic understanding of company sales and service processes, and company proprietary systems
Possesses the ability to work with diverse groups of people, including financial professionals, home office associates, and firm management
Financial services industry experience is a plus, as well as recent exposure to insurance and broker/dealer laws and regulations, company compliance policy, and a basic familiarity with Prudential products and services, systems and processes
Firm experience is a plus for this position
The successful candidate is highly encouraged to obtain the Series 7 & 24 within one year of hire

Associate Regulatory Program Director Resume Examples & Samples

Job level: Individual contributor
Team Member: TRT, site(s) technical teams, global technical teams (e.g. submission teams, expert teams as appropriate)
Network: Site and Global Experts, PTR International Operations,

Associate, Regulatory Administration Advisor Resume Examples & Samples

Minimum of 5 years of experience as an attorney/senior paralegal in any of the following organizations
Mutual fund organization (adviser, distributor)
Fund Administrator (custodian bank/ transfer agent/service provider)
Mutual fund regulatory and compliance (i.e., SEC filings, prospectus drafting and filing, preparing Board materials, attending Board meetings, portfolio compliance, etc.)
Mutual fund processing operations knowledge (i.e., transfer agency, fund accounting, custody)
Regulatory exams/inspections: SEC, OCC, Fed, FDIC, etc

Associate Regulatory Affiars Resume Examples & Samples

Review and evaluate technical and scientific data and reports required for submission
Label reviews
Tracking submissions

Senior Associate Regulatory Sciences Switzerland Resume Examples & Samples

Support regulatory processes in line with business and R&D objectives to ensure timely registration of new products, line extensions, and maintenance and renewals of BMS approved products in Switzerland
Submit clinical trial applications in Switzerland in line with BMS company policies and practices and national guidelines
Work with local Medical, Marketing, Market Access, Global Labelling, Global Manufacturing & Supply to ensure the regulatory aspects of labelling are in compliance with local legislation and BMS requirements
Ensure the archiving of regulatory files and documentation and maintenance of regulatory databases for assigned tasks
Support multi-functional teams (Brand Team) with regulatory aspects
Acquire working knowledge and understanding of BMS products and regulatory processes while working under supervision from the GRS Director or GRS Manager
Pay strict attention to detail and accuracy whilst maintaining a sense of urgency. Deliver high quality regulatory work to ensure regulatory objectives are met
Establish and maintain co-operative working relationships with peers and co-workers
In support of regulatory objectives, continue to upgrade experience by participating in BMS sponsored training to develop technical skills, communication effectiveness, and leadership potential
Master of Science degree, preferably in medical, pharmaceutical or related studies is required. PhD is of advantage
Knowledge in regulatory activities, including: marketing authorization, clinical trial submissions and life-cycle management activities
Ability in planning, problem solving, and time management
Be comfortable working in a matrix organization
Proven ability to navigate effectively in a multi-cultural environment with the ability to communicate across all levels and functions of a global organization
Be highly proficient in German and English. French is of advantage
Good computer skills in a variety of applications e.g. Microsoft office
Be a team player and collaborative in approach
Ability of independent scientific thought, and the capacity to learn and understand new scientific concepts and ideas
Passion: We pursue excellence to help patients prevail. I set high standards for myself and others to win for our patients / I energize others / I strive to learn something new every day / I treat my patients, customers and colleagues with compassion, empathy and respect
Innovation: We embrace new ideas. I challenge the status quo / I seek and share bold idea that help BMS win / I pursue and understand diverse perspectives outside of BMS / I encourage and have constructive debates / I embrace change to drive innovative outcomes / I rebound quickly and learn from my mistakes
Accountability: We own our outcomes and the outcomes of others. I own BMS? Success by holding myself and others accountable / I share information in a transparent and honest way / I celebrate my successes and the successes of others / I coach and mentor others with good intent and purpose / I am inclusive and bring out the best in others / I understand what people do and the impact I have on them
Speed: We act with urgency and agility. I work with a sense of urgency / I focus on what’s important / I consult with the right people to move quickly / I seek efficient, effective solutions / I quickly assess potential risks and rewards / I break silos and eliminate unnecessary rules / I make decisions with resolve and enable others to do the same

Associate Regulatory Prooduct & Operations Specialist Resume Examples & Samples

Bachelor’s degree in any field and 2 years of experience in a Medical Device or similar regulated industry
High Level of proficiency using MS Excel and MS Word
High learning aptitude and adaptability with software systems
Demonstrated technical writing skills
Multi-tasks and prioritizes effectively in fast-paced environment
Team player who seeks to help and learn from colleagues seeing the department success as their own
A problem solver and critical thinker that relies on own judgment for appropriate level of decision making
Demonstrated leadership qualities
Ability to manage small scale projects to completion within and outside of the direct department
Proactively seeks to develop and become well-versed within in the regulatory landscape

Senior Associate, Regulatory Solutions Resume Examples & Samples

Be a fast learner, able to pick up and understand new requirements seamlessly and adapt quickly to new approaches and technologies within the regulatory environment
Work proactively to develop and implement new logical treatments of new interpretations within the regulatory and analytics space
Adapt to work on several projects in parallel
Contribute to the ideas-based culture of the team, by suggesting possible new projects, or new (improved) approaches to existing projects
Excellent MS Excel skills
Strong understanding of capital markets products (especially Fixed Income and Derivatives)
Composed, experienced and professional in client interaction
A logical mind, capable of implementing and improving structured processes
Demonstrable experience of tailoring solutions to meet specific requirements, and subsequently attempting to automate

Senior Associate, Regulatory Consulting Resume Examples & Samples

Participate in regulatory reviews of financial services firms assessing the strength of governance, compliance and risk frameworks, and to identify control failings and operational weaknesses
Participate in regulatory due diligence work on behalf of firms preparing for sale, and on client acquisition targets
Participate in regulatory consulting projects to provide advice to financial services firms on regulatory matters to assist them in meeting regulatory expectations
Conduct research, keeping up to date with current regulatory developments and writing guidance notes and articles for distribution both internally and externally

Associate Regulatory Product & Operations Specialist Resume Examples & Samples

Collaborate and support RBUs to determine local regulatory pathways, requirements and timelines
Collaborate with, and support RBUs by providing the documentation necessary to prepare in-country regulatory submissions. Including, but not limited to obtaining Certificates to Foreign Government, Letter of Authorization, technical reports, and the notarization of documents
Collaborate with and support RBUs in coordinating international regulatory activities on behalf of the Surgical Innovations business
Ensure the timely and accurate filing of regulatory documentation
Develop and maintain product technical files
Maintain product licenses by providing annual notifications as required by specific regions
Assist in the development, documentation, and implementation of regulatory strategies for new technologies and product modifications to include applicable international requirements
Provide regulatory affairs support to new product development teams
Provide regulatory affairs support to design and change control teams to assess regulatory impact of design changes
Actively maintain and report registration status with applicable registration trackers and applications
Perform other regulatory affairs duties when requested
Interface with quality, operations, clinical, regulatory, sales, marketing, and administrative staff as necessary to accomplish the above responsibilities
May have to travel internationally
Ensures rapid and timely responses to requests from regulatory agencies and third party registrars
Completion and distribution of vendor surveys along with supporting documentation to allow products to be sold and used in various custom kit configurations
Bachelor’s degree in a scientific or engineering field
0 – 2 years related experience in a technical job function/role, depending on degree type
Experience in a regulated industry, preferably medical devices, with an emphasis in regulatory or quality assurance
Experience using ERP software (BPCS/SAP preferred), electronic filing systems, and/or databases
Ability to interface effectively with individuals from a wide variety of disciplines to research and obtain appropriate documentation for the submission of regulatory information
Ability to prepare and submit regulatory documentation packages
Working knowledge of MS Access, MS Project, and Adobe Acrobat Pro
Highly organized, detail oriented, and efficient
Strong interpersonal and negotiation/influencing skills while maintaining a high level of professionalism

Associate, Regulatory Global Labeling Resume Examples & Samples

0-3 years’ experience (2-5 years or a Masters for Associate II). Working knowledge of FDA and EU labeling regulations/guidance a plus
Have a passion for quality and an impeccable detail orientation
Strong planning and organizational / project / workload management skills
Thrive in, and be able to work in, a fast paced environment
Technology savvy: extensive experience in PC-Based word processing software, databases and spreadsheets, including Microsoft Office Word and Excel, Adobe Acrobat and MS Project
Familiarity with SPL, PLR, QRD templates and other formatting requirements
Solid interpersonal (verbal and written) communication skills at all levels (peers to executive management)
International labeling experience including Latin America, APAC Regions, and MENA CIS Regions desirable
Knowledge of medical terminology a plus

Associate Regulatory Reporting Production Support Resume Examples & Samples

BS/BA in Accounting or Finance and 3+ years relevant Regulatory Reporting work experience
Regulatory Capital knowledge and Axiom experience a plus
Experience executing UAT including issue identification and resolution
Ability to manage people, be highly self-motivated and promote teamwork
Excellent analytical, quantitative and problem solving skills including the ability to renovate existing processes
Strong communication, organizational and time management skills
Ability to interact well with others at all levels
Ability to handle and resolve recurring challenges and problems

Associate Regulatory Project Director Resume Examples & Samples

Provide regulatory expertise on procedural and documentation requirements as defined by Health Authorities for assigned deliverable(s) including
Relevant University Degree in Science or related discipline
Extensive regulatory experience within the biopharmaceutical industry, or experience at a health authority
Thorough knowledge of drug development
Leadership skills, including experience leading multi-disciplinary project teams
Managed first wave Marketing Application and/or LCM submissions
Managed complex regulatory deliverables across projects/products
Influencing and stakeholder management skills