Regulatory Scientist Resume Samples

The Guide To Resume Tailoring

Guide the recruiter to the conclusion that you are the best candidate for the regulatory scientist job. It’s actually very simple. Tailor your resume by picking relevant responsibilities from the examples below and then add your accomplishments. This way, you can position yourself in the best way to get hired.

Craft your perfect resume by picking job responsibilities written by professional recruiters

Pick from the thousands of curated job responsibilities used by the leading companies

Tailor your resume & cover letter with wording that best fits for each job you apply

Resume Builder

Create a Resume in Minutes with Professional Resume Templates

CHOOSE THE BEST TEMPLATE - Choose from 15 Leading Templates. No need to think about design details.

USE PRE-WRITTEN BULLET POINTS - Select from thousands of pre-written bullet points.

SAVE YOUR DOCUMENTS IN PDF FILES - Instantly download in PDF format or share a custom link.

Create a Resume in Minutes

B Vandervort

Breana

Vandervort

47760 Elroy Heights

Detroit

+1 (555) 678 5992

47760 Elroy Heights

Detroit

Phone

p +1 (555) 678 5992

Experience Experience

Phoenix, AZ

Regulatory Scientist

Phoenix, AZ

Kling, Watsica and Vandervort

Phoenix, AZ

Regulatory Scientist

Manage technical product documents, including retrieval, review, modification, and storage
Provide international regulatory support for new market openings
Collaborate with cross functionally and with suppliers to obtain accurate regulatory documents in a timely manner
Leverage knowledge of key processes and stakeholders to navigate the organization effectively and achieve results
Address regulatory import/export issues and collaborate cross-functionally to develop solutions that meet business objectives and ensure compliance
Lead conference calls with regional and/or in-market contacts to support international product registrations, receive and provide regulatory updates, and align on best practice
Request, review, approve, disseminate, and/or store technical information

Chicago, IL

R&D Regulatory Scientist

Chicago, IL

Cassin-Haley

Chicago, IL

R&D Regulatory Scientist

Providing regulatory guidance to RD&Q, PCMs, Marketing, Consumer services
Artwork Approval
Providing technical information on products to answer enquiries from local Authorities
Coordination and Information of the regulatory network
Supporting managers
LABEL spec generation, PROD spec review including H&W policies, Master Artwork Review
Priority Setting

present

Los Angeles, CA

Senior Reach Regulatory Scientist

Los Angeles, CA

Moen Inc

present

Los Angeles, CA

Senior Reach Regulatory Scientist

present

Growing and driving the business forward and securing new projects, identifying and developing new business opportunities for the company
Providing regulatory strategy and advice relating to the EU REACH scheme
Acting as the primary client contact and ensuring that registrations are delivered to a high standard, on time, and within agreed budget
Managing complex REACH projects and providing high level technical and regulatory consultancy services to industrial chemical clients
Mentoring and managing members of the industrial chemicals team
Keeping up to date with developments in the field of chemical regulations, particularly with regard to REACH and worldwide industrial chemical notification schemes
Promoting Exponent’s services, particularly in the fields of REACH and new chemical notifications

Education Education

Bachelor’s Degree in Food Science

Webster University

Bachelor’s Degree in Food Science

Skills Skills

Ability to assimilate new information quickly and react positively to new and challenging opportunities
Excellent verbal and written communication skills and will be capable of simplifying complicated technical subjects to present to non-technical audiences
Ability to multitask, maintain attention to detail and remain calm under pressure
Ability to manage multiple priorities and deliver accurate outcomes
Ability to identify gaps and drive improvements
Ability to communicate technical information to non-technical partners in a clear and concise way
Spanish speaker highly recommended
Ability to navigate through ambiguous and unstructured situations
Ability to communicate effectively and influence internal and external stakeholders
Ability to build relationships with key stakeholders

Create a Resume in Minutes

15 Regulatory Scientist resume templates

Read our complete resume writing guides

Regulatory Scientist Resume Examples & Samples

Manage technical product documents, including retrieval, review, modification, and storage
Provide international regulatory support for new market openings
Collaborate with cross functionally and with suppliers to obtain accurate regulatory documents in a timely manner
Leverage knowledge of key processes and stakeholders to navigate the organization effectively and achieve results
Address regulatory import/export issues and collaborate cross-functionally to develop solutions that meet business objectives and ensure compliance
Lead conference calls with regional and/or in-market contacts to support international product registrations, receive and provide regulatory updates, and align on best practice
Request, review, approve, disseminate, and/or store technical information
Build regulatory expertise
Inform internal team members of regulatory changes, and begin developing as a subject matter expertise
Collecting, reviewing, and managing technical product information: (1-3 years)
Researching international food and beverage regulations and registering products in foreign markets: (1-3 years)
Consulting cross-functional team members on regulatory requirements: (1-3 years)
Familiarity with product development, creative, and commercialization processes for a food and beverage company: (1-3 years)
Spanish speaker highly recommended
Bachelor’s degree in Food Science, Nutrition, or related field
Computer proficient, savvy with MS Excel and Outlook
Ability to handle large volumes of technical data in an organized manner, analyze it, and recommend solutions
Ability to build relationships with key stakeholders
Ability to identify gaps and drive improvements
Ability to communicate technical information to non-technical partners in a clear and concise way
Ability to assimilate new information quickly and react positively to new and challenging opportunities
Ability to navigate through ambiguous and unstructured situations
Ability to communicate effectively and influence internal and external stakeholders
Ability to manage multiple priorities and deliver accurate outcomes
Ability to multitask, maintain attention to detail and remain calm under pressure

Regulatory Scientist Resume Examples & Samples

Collaborate with suppliers/partners to obtain accurate regulatory documents in a timely manner
Address regulatory issues and collaborate cross-functionally to develop solutions that meet business objectives and ensure compliance
Lead conference calls with regional and/or in-market regulatory contacts to support international product registrations, receive and provide regulatory updates, and align on best practice
Inform internal team members of changes, and begin developing as a subject matter expertise
Years of experience: (0-3 years minimum)
Collecting, reviewing, and managing technical product information: (0-3 years)
Researching international food and beverage regulations and registering products in foreign markets: (0-3 years)
Consulting cross-functional team members on regulatory requirements: (0-3 years)
Bachelor’s degree in Food Science, Nutrition, International Business or related field

Regulatory Scientist Resume Examples & Samples

Experience with qualitative and quantitative safety and efficacy data sets
Knowledge of regulatory health
Knowledge of FDA regulatory requirements
5+ years of experience with project management
5+ years of experience with business development in the government, biotechnology, pharmaceutical, or life science sectors
Experience with product surveillance and safety pharmacovigilance
Experience with consulting
Knowledge of CDISC data standards
BS degree in a life sciences field
Regulatory Affairs Certification (RAC)

Reach Regulatory Scientist Resume Examples & Samples

Managing and assisting in the completion of complex REACH projects
Providing technical and regulatory consultancy services to industrial chemical clients
Assessing our client’s obligations under the REACH legislation and development of appropriate regulatory strategies to enable them to meet these requirements
Contributing to the generation of technical documents required for REACH registrations, as well as being responsible for successful completion of projects
Advising on regulatory strategy and the EU REACH scheme
Keeping up to date with developments in the field of chemical regulations, particularly with regard to REACH and worldwide industrial chemical notification schemes
BSc degree or above in Biology, Chemistry or another related scientific field
Ability to work independently and also with a team
Excellent communication skills and used to working under pressure and deadlines
Proven experience of data interpretation
Ability to demonstrate sound judgement and decision-making

Senior Reach Regulatory Scientist Resume Examples & Samples

Providing regulatory strategy and advice relating to the EU REACH scheme
Managing complex REACH projects and providing high level technical and regulatory consultancy services to industrial chemical clients
Growing and driving the business forward and securing new projects, identifying and developing new business opportunities for the company
Acting as the primary client contact and ensuring that registrations are delivered to a high standard, on time, and within agreed budget
Promoting Exponent’s services, particularly in the fields of REACH and new chemical notifications
Mentoring and managing members of the industrial chemicals team

Regulatory Scientist Resume Examples & Samples

Managing and tracking client projects, project deliverables and budgets
Interacting with internal project staff to discuss client projects, tasks, deliverables and budgets
Editing and proofreading complex regulatory and technical reports
Providing regulatory and technical review and quality control support for FIFRA and related projects
Reviewing literature and regulatory guidance documents as it relates to projects
Synthesizing technical and regulatory information
Monitoring and processing invoices related to project work and studies
Interacting with clients
Coordinating with laboratories related to project work
Organizing and assisting with the daily activities of the practice
Preparing client presentations
Performing literature and internet research as related to project work
Bachelor or Master’s degree in a Science or related field
Excellent communication, writing, editing and proofreading skills
Must be detail oriented, able to work independently, and manage time effectively
Strong ability to organize and prioritize multiple projects with competing deadlines
Excellent interpersonal skills and ability to work in a collaborative environment
Experience in a scientific and/or research environment a plus
Experience with project management, budget tracking, and invoicing a plus
Strong working knowledge of Access, Excel, Word, PowerPoint, Outlook, Adobe and Internet Explorer required, experience with MS Project a plus
Exposure to sensitive information will necessitate considerable use of tact, diplomacy, discretion, and judgment

CMC Regulatory Scientist Resume Examples & Samples

Bachelor’s Degree with 5-7+ years OR Master's with 3-5+ years with pharmaceutical industry experience in CMC technical drug development
Prior experience authoring CMC submission content is desirable
Biotechnology experience in biologics strongly preferred
Demonstrated strong written, spoken and presentation communication skills
Demonstrated negotiation and influence skills
Demonstrated effective teamwork skills; able to adapt to diverse interpersonal styles

Regulatory Scientist Resume Examples & Samples

Experience with conducting market and patent analysis in the oncology, virology, neuropsychology, drug delivery, and bioinformatics fields
Ability to evaluate biomedical technologies, including wearables and vaccines
Ability to design and execute collaborative cancer biology projects, as needed

Regulatory Scientist Resume Examples & Samples

Assure accurate, reliable and timely regulatory checks, specifications, documentation, internal approvals, label compliance and local approvals/product registrations (if requested) in the area of responsibility to enable implementation of business goals
According to business plans and strategies, execute SARA work for all Mondelēz International food categories in Nordic but mainly for chocolate and chocolate related brands for labelling and compliance check to enable implementation of growth, productivity and brand maintenance goals
Interact and communicate as a regulatory partner with multiple functions, work in close cooperation with product/ packaging development, marketing, supply chain, quality, country management and product change partners in our business units and plants
Create product labeling information including ingredient declarations, allergen information and nutrition labeling using Meridian specification system for Nordic market
Support Consumer relations teams with queries regarding all Mondelēz International products dedicated for Nordic market under guidance from management
Ensure position's alignment to Mondelēz International vision and values as its compliance to ISO 9001/14001 /18000/22000 quality, food safety, labour safety and security, environment, health and safety management systems‘ requirements, company QCMS, laws, standards, Mondelēz International privacy policy, data protection principles and Mondelēz Europe Services GmbH internal policies and procedures' requirements, other Mondelez polices regulations
Bachelor's or equivalent in Food Chemistry, Food Technology, Food Science or Nutrition or other relevant discipline
Reliable, accurate and attention to detail
Fluent in Norwegian (written & spoken)
Fluent in English (written & spoken)
Fluent in another language(s) (Nordic language)
Proactive team worker with organizational / project management skills
Working experience in Regulatory Affairs or a Quality function
Experienced in working in an international and multifunctional environment

Lead Regulatory Scientist Resume Examples & Samples

Represents UK Regulatory Affairs both externally and internally as UK affiliate to the Roche Development organisation and other Regulatory affiliates
Build contacts and understanding across the business, to optimise current and future Regulatory activities
Proactively seek knowledge in specialist areas, interpret and communicate impact analysis within Regulatory Affairs and across relevant business areas
Ensures high quality regulatory submissions are made in a timely manner in collaboration with colleagues to maintain licences compliantly. Ensure approved changes are implemented
Be able to find, understand and apply regulations and guidance relevant to our work
Provide specific guidance on regulatory issues to support internal customers
Act as primary regulatory product contact for assigned products cross functionally, interfacing with local medical and marketing teams and Headquarters Regulatory
Know the brand strategies. Timely communication of regulatory activities and timelines to support brand planning
Assess technical/scientific content of proposed national submissions to meet requirements. Propose solutions to correct deficiencies
Ensures questions and commitments from our national regulatory authorities (UK, Ireland, Malta) are proactively managed
Be able to coach less experienced colleagues in their work
Contribute to efficiency and process improvement, including development of best practices, SOP maintenance and appropriate tracking tools, templates
To ensure that personally and within the team: High ethical standards are maintained at all times, there is full compliance with all applicable laws, regulations, industry codes and internal policies and procedures

Regulatory Scientist Resume Examples & Samples

Support GRL to lead the delivery of timely approvals and product information in keeping with the needs identified by the business and markets and in compliance with relevant UCB procedures and local country regulations
Provide regulatory expertise on regulatory submissions, health authority briefing documents and response documents
Assume assigned responsibilities for routine and non-routine contact with health authorities and affiliates to support the GRL
Delivers project assignments supporting the business e.g. representation on functional workstreams
Assist in development of regulatory standards and SOPs
Flexibility and adaptability - Decides what to do based on the situation. Changes behavior or approach to fit the situation or the person. Works effectively in ambiguous situations
Communication skills – knows when and how to communicate, using strong interpersonal skills and written communications when appropriate
Results focused – ability to overcome obstacles and achieve key outcomes
Analytical – logically breaking situations or issues down into their essential elements: carrying out diagnosis and developing solutions
Organizational Skills with an a high level of attention to detail
Integrity – overriding commitment to integrity and high standards in self and others
Build effective partnerships – identifies opportunities and takes actions to build effective relationships within team and with other areas
Influencing skills - through well thought through rationale and effective communication skills, able to influence key decisions

Regulatory Scientist Intern Resume Examples & Samples

Search and review scientific literature and regulatory publications to summarize key insights on a given topic to help develop product regulatory strategy
Provide regulatory and scientific guidance to Cargill Food Ingredient business units
Develop and manage scientific substantiation and reports to support product claims and regulatory compliance
Review collateral marketing materials for accuracy of health benefit related statements and regulatory compliance
Currently pursuing a M.S., or Ph.D. in Food Science, Food Technology, Nutrition, Toxicology, Pharmacology, Chemistry or related science degree
Demonstrated organizational skills and attention to detail
Skilled in conducting relevant literature search, review and evaluation of scientific literature, and summarization of key findings
Moderate to advanced scientific knowledge: chemistry, acids &bases, solvents, biology/microbiology, food science
Strong interest in Regulatory career path post-graduation
Strong leadership and technical skills
Moderate computer skills (word processing, spreadsheets, and database navigation)

R&D Regulatory Scientist Resume Examples & Samples

Products Labelling Reports (PLRs) generation for local brands for the country of scope
Regulatory key contact in the EU project team
Coordination and Information of the regulatory network
Deviations pre-review (preparation of the consolidated regulatory assessment)
Preparing answers to consumer queries or to other internal/external people
Artwork Approval
Supporting managers
Support for cross-category/cross functional projects
Food Sciences University Degree
Food Industry experience
Flexibility
Fluent Englis both written and spoken
Fluent Czech is a must

R&D Regulatory Scientist Resume Examples & Samples

PLRs Translation
Simple Artwork Approval
Collecting data
Contributing to the training and introduction of newcomers
Bachelor/Master or equivalent in Food Chemistry, Food Technology, Food Science or Nutrition is a must
Experienced in Scientific & Regulatory Affairs, Quality, R&D will be an asset
Detailed oriented
Fluent in Lithuanian (written & spoken)
Russian fluency wil be additinal asset

Senior Regulatory Scientist Resume Examples & Samples

You will develop, implement and communicate regulatory science strategies and defend them to internal and external stakeholders
You will plan and conduct all agreed studies to investigate the metabolism in plants and animals with a strong focus on animal metabolism studies
You will also be responsible for other regulatory activities (e.g. dossiers, risk assessments) according to compliance, safety and financial requirements
You have successfully completed your studies in natural sciences (Master/Diploma/Ph.D.) or veterinary medicine
Besides your profound experience in project management, you are able to present results and lead discussions professionally
You are well acquainted with the standard IT applications and are versed in using your excellent English language skills on a daily basis at work
In addition to driving innovations and sustainable solutions, you also collaborate for achievements and communicate effectively

Reach Regulatory Scientist Resume Examples & Samples

BSc degree or above in Chemistry, Biology or Environmental field
Proven experience of clearly and concisely summarising scientific data
Experience of data interpretation
Must be able to work autonomously
Excellent written and verbal communication skills with attention to detail
Proficient in the use of Microsoft packages
Able to work under pressure to time constraints and deadlines
Self-motivated and organised
Experience using the IUCLID software package
Consultancy experience

Regulatory Scientist Resume Examples & Samples

Serve as a regulatory compliance subject matter expert for Stepan’s biocide business
Contribute to the submission and maintenance of Stepan’s pesticide registrations at the state and federal level. under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and related regulations
Monitor federal regulations related to Stepan’s pesticide products
Implement compliance-related activities on Stepan’s behalf with state and federal agencies; customers and internal compliance efforts
Familiarity with and ability to review and proofread pesticide product labels
Ability to act as a Regulatory Liaison to Stepan’s Business and Sales Divisions
Ability to build constructive relationships and interface with Stepan customers, as well as state and federal regulators
Represent Stepan at trade association conferences and industry meetings
Managing or directing the work of one or more project team members
Engages with project teams and contributes regulatory strategies and tactics on products of interest inside and outside the company
Bachelors Degree with technical background such as Chemistry or similar field with a minimum of 5-8 yrs exp
Advanced Degree preferred
Preferred knowledge of FIFRA regulations/standards
Experience preparing government submissions for biocide or antimicrobial pesticide product registrations at the state or federal level, conducting compliance audits, or manufacturing experience preferred

R&D Regulatory Scientist Resume Examples & Samples

PLR translation review and local approval for MEU brands sold in France and/or Benelux
Labelling coordinator role for a MEU brand
Fluent in French or Dutch (ideally both)
Good notions of Spanish will be an additional asset

Regulatory Scientist Resume Examples & Samples

University degree in Food Chemistry, Food Technology, Food Science or Nutrition
Experience in Scientific & Regulatory Affairs, Quality, R&D
Experience in food industry as an advantage
Fluent English (written & spoken); other European languages as a plus

Regulatory Scientist Resume Examples & Samples

Conducting consultancy work in the Biocides sector
Project Management of work programmes, including budget, communication, Quality Assurance, delivery
Preparation of technical reports and dossiers
Product support in a regulatory setting
Developing and implementing strategies for EU and global regulatory authorisations; provision of regulatory advice
Contributing to expansion of Biocides business
BSc degree or above in Biology, Chemistry or another related field
Proven experience of working in a Biocides Regulatory Environment
Strong networking and interpersonal skills
Forward looking, creative and a strategic thinker
Excellent presentation and communication skills

Manager, Regulatory Scientist, Oncology Resume Examples & Samples

A Bachelor's degree in a scientific field and a minimum of 8 years of overall professional experience is required; OR an advanced degree (MS, PharmD, or PhD) and a minimum of 4 years of overall professional experience is required
Regulatory Affairs experience is strongly preferred
Understanding of the drug product lifecycle from discovery to marketing is required
Medical/scientific understanding of clinical trials is strongly preferred
Knowledge of HA organizational structure and HA processes for reviewing submissions is required
Experience with companion diagnostics, combination products and/or biomarker development is preferred
Strong knowledge of oncology disease area and landscape is preferred
Strong knowledge of FDA, ICH Regulatory requirements and guidelines specific to the areas of clinical research, product development, and labeling is required
Proven experience working within a collaborative team environment as an individual contributor and decision maker within a cross-functional organization is required
Proven experience effectively prioritizing assignments for multiple products and projects simultaneously is required
Limited travel (less than 10%) may be required
The preferred location for this position is Raritan, NJ, but can also be located in Spring House, PA

Regulatory Scientist Resume Examples & Samples

Interacting with other groups within Global Regulatory Affairs (GRA) and beyond, as needed, to manage and resolve cross-functional issues
Actively supporting Global Regulatory Leads (GRLs) as assigned
1) Responsible for executing regulatory strategies that result in successful regulatory submissions, approvals and renewals for assigned products
2) Responsible for the compilation of high quality regulatory documentation
3) Leads or facilitates the development of core briefing documentation and supports regulatory agency meetings, regulatory advisory committee meetings, scientific conferences or equivalents
4) The Regulatory Scientist assists in the development and review of local labeling in accordance with the Company Core Data Sheet (CCDS)
5) In collaboration with cross-functional partners, develops and reviews post marketing periodic safety reports and contributes to the safety and efficacy risk assessment for assigned products, as required
6) As needed, represents GRA DP at the GRA internal product strategy team, i.e. GRAST and at cross-functional teams with clinical and/or safety focus, i.e. Life Cycle Management (LCM) meetings
7) Identifies relevant guidance documents, international standards and regulatory rule changes related to clinical/ safety product life-cycle management. Ensures appropriate communication within GRA and CSLB
8) Assists with compliance activities (including appropriate electronic systems), to ensure consistency, completeness, and adherence to global regulatory standards for all regulatory submissions. This may include initiation, development, review and update of departmental procedural documents such as SOPs and Working Instructions
Preferably 2-3 years’ pharmaceutical industry experience. Regulatory (including CMC regulatory) experience is highly desirable
Knowledge of local regulatory requirements/guidelines in an ICH region (US, European Union, or Japan)
Knowledge of and understanding of post-approval regulatory maintenance processes
Knowledge of scientific and clinical research terminology

Regulatory Scientist Resume Examples & Samples

Preparing high-quality regulatory submission documents relating to dietary exposure and risk assessment of consumers of food crops treated with crop-protection chemicals, to include summaries of study reports, exposure and risk assessment calculations and overall conclusions
Developing knowledge and experience in the areas of crop and livestock metabolism, residues, processing and other study types
Sound judgement
Regulatory/authorisation procedures for crop-protection chemicals, biocides or industrial chemicals
Interpretation of data from scientific studies

Regulatory Scientist Resume Examples & Samples

Contribute to the submission and maintenance of Stepan’s pesticide registrations at the state and federal level under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and related regulations,
Review and proofread pesticide product labels
Act as a Regulatory Liaison to Stepan’s Business and Sales Divisions
Build constructive relationships and interface with Stepan customers, as well as state and federal regulators
Manage or direct the work of one or more project team members
Engage with project teams and contribute regulatory strategies and tactics on products of interest inside and outside the company
Bachelors Degree with technical background such as Chemistry or similar field
A minimum of 5-8 years experience
Knowledge of FIFRA regulations/standards preferred

Regulatory Scientist Resume Examples & Samples

Participate in global regulatory team meetings as appropriate
Advise the regulatory team on applicable regulatory requirements, project specific regulatory issues as assigned
Develop an understanding of the regional regulatory environment, competitor intelligence and therapeutic area
Act as back-up for contact with Regulatory Agencies as needed
Draft cover letters for Regulatory Agency communication
Assist in the preparation of meetings with Regulatory Agencies
Liaise with LOCs, and ensure responses to queries are made in a timely manner, and that content is consistent with the regulatory strategy
Assist in development and improvement of processes related to regulatory submissions
An advanced degree (MS, Pharm D, PhD) is highly preferred, a minimum of a Bachelor’s Degree is required
1+ year relevant experience with an advanced degree OR 4+ years with a Bachelor’s Degree is required
Pharmaceutical industry experience
Understanding of the drug development process and regulatory submission and approval process
Knowledge of the regulatory environment, US guidelines and practices
Direct experience in regulatory affairs is desirable

Regulatory Scientist Cimzia Resume Examples & Samples

Support the Global Regulatory Leader (GRL) for the delivery of timely approvals and product information in keeping with the needs identified by the business and markets and in compliance with relevant UCB procedures and regional/local country regulations
Lead the planning, preparation and delivery of both simple and complex submissions throughout the product’s life cycle from either a global and/or regional perspective
Liaise proactively with the functions and participate as a member of cross-functional delivery teams for complex submissions, providing regulatory advice
Identify potential regulatory risks to the operational plan, and propose options to mitigate risks
Maintain awareness of competitors’ activities and share potential impact these activities may have on the product development program
Ensure that appropriate, up-to-date records are maintained for compliance
Provide input into Regulatory Strategy Plans and project budget as delegated by GRL
Assist in due diligence activities for in-licensing opportunities

Regulatory Scientist Resume Examples & Samples

Preferably have a Masters or Ph.D degree in food toxicology, organic chemistry, analytical chemistry, polymer chemistry, biochemistry, biology, or related field
Post-graduate professional status/training related to toxicology (e.g. DABT), food science, packaging safety evaluation, risk assessment, or clinical sciences desirable
A minimum of 5-10 years of related work experience in a government, food industry, or food packaging industry role with an emphasis on Food Safety/Toxicology including an understanding of the properties, safety, effects, and detection of substances in foods and/or food packaging
Experience and/or training in the US and global regulation of food, pharmaceutical, and biomedical contact substances desirable
Proficiency in computer software such as Microsoft Word, Excel, and Power Point is required
Self directed and require minimal direction from management
Candidates should be able to exercise appropriate judgment to make decisions that support strategic company objectives
Organized and accurate in work
Excellent verbal and written communication skills and will be capable of simplifying complicated technical subjects to present to non-technical audiences
Candidate should also be able to effectively interact with all levels of associates (from production floor to senior management)
Provide regulatory and scientific support to the Regulatory staff and other internal business partners to support existing product lines, changes, and innovation projects in support of the company’s strategic initiatives. Work closely, particularly with R&D, to ensure product compliance in development
Establish appropriate material testing protocols as needed to assess existing and new materials and products (typically migration testing). Review and interpret associated testing results
Communicate and interact with parties external to Printpack such as customers, suppliers, industry groups, and regulatory agencies as necessary to perform the functions of the role
Represent Printpack on scientific committees and in various industry and technical organizations related to food packaging regulatory compliance and report back on activities
Serve as the company subject matter expert for packaging related chemical substances, toxicology, food packaging migration studies, and risk assessments
Monitor and stay current on emerging issues related to food packaging safety, chemistry, toxicological information, and regulations for food, pet, and medical packaging. Complete analyses on the potential impact of these areas to Printpack’s business and communicate and collaborate internally on these topics
Participate in maintaining and development of Printpack’s regulatory policies, guidelines, and procedures. Assist with design, implementation, and monitoring of systems and programs to ensure food safety and regulatory compliance of Printpack’s products based on scientific methodology

Senior Regulatory Scientist, G&C Resume Examples & Samples

Manages/lead regulatory input on project teams for large to major-sized projects, including those with multiple business partners. Project scope could involve several sub-projects. Works with the Category Regulatory lead for G&C MEU to allocate projects across the G&C Regulatory team
Independently conducts relevant legal compliance checks (ingredients, recipes, specifications, claims) and nutritional profiling and prepares appropriate documentation including labelling data and artwork approvals in an accurate, reliable and timely manner to support product launches. This work will encompass European and local projects as required to support the G&C category
Issues PLRs & Local implementation
Artwork Approval
Ensures consistency, technical precision and compliance with methods of work. Identifies new opportunities or improvements in programs within department
Effectively structures and presents status updates / proposals to influence partners or share with higher management (up to and including Director-level). Interfaces independently with Senior Management and external partners
Has an established network with business partners within and across categories, with particular emphasis on building proactive relationships with colleagues in MEU, EMEA & Global G&C Category to ensure early regulatory involvement in all relevant activities
Builds expertise in one or more specialised areas of Regulatory Affairs to enable them to be seen as a leader in this area within the KFE SARA community. Trains others within department on range of topics within own scientific discipline
University Degree or equivalent in Food Chemistry, Food Technology, Food Science or Nutrition
Good Knowledge in EU food regulations and at least 1 Member State
Experience of practical application of food regulations in a commercial environment or trade association
Deep product, technology and quality understanding
Excellent knowledge of internal requirements, policies and guidelines
Familiar with quality systems, processes including specifications management systems
Excellent cross-functional and external organizational skills, including time management and priority setting
Ability to work independently and solve problems independently
Strong project management skills (including project plans, updates, flagging derailers on time, etc.)
Fluency in English. Fluent in other EU language (French, German, Dutch) as a plus