Regulatory Affairs Labelling Manager Job at Proclinical (Hertfordshire)

Quality & Regulatory Affairs Manager

We’re looking for a Quality & Regulatory Affairs Manager who’s passionate about ...

Location

United States; Canada , Boston; Chicago; Ottawa; Toronto

Salary:

Not provided

Fullscript

Expiration Date

Until further notice

Requirements

5+ years of progressive experience in regulatory affairs or quality compliance within dietary supplements and/or NHPs
Working knowledge of FDA dietary supplement regulations (21 CFR 111, DSHEA, NSF 455-2) and Health Canada NHP frameworks
Experience supporting or preparing for FDA, NSF, or Health Canada inspections
Proven ability to manage labeling, claims, supplier documentation, and GMP records with precision
Strong communicator with the confidence to collaborate across teams and influence without authority
Bachelor’s degree in life sciences, chemistry, or a related field

Job Responsibility

Maintain ongoing compliance with FDA 21 CFR 111, DSHEA, and NSF 455-2 for finished dietary supplements
Manage Health Canada NHP site and product licensing, importation compliance, and regulatory documentation
Review and approve labels, claims, and substantiation for dietary supplements and NHPs
Support audit readiness for FDA, NSF, and Health Canada inspections, including CAPA documentation and process follow-up
Oversee facility registrations, supplier qualifications, and product listings across U.S. and Canadian markets
Partner with Quality, Legal, and Distribution to resolve compliance issues and strengthen product lifecycle controls
Monitor regulatory updates and proactively align internal processes to new requirements
Contribute to SOP, QMS, and continuous improvement initiatives that reinforce Fullscript’s compliance excellence

What we offer

Market competitive compensation package including equity
401K matching (within US)//RRSP matching (within CAD)
Flexible PTO policy
Flexible benefits package and additional perks
Employee discount on Fullscript catalog of products for family & friends
Ability to *Work Wherever You Work Well*

Fulltime

Regulatory Affairs Manager

As an active member of the Regulatory Affairs team, this position will participa...

Location

United States , New York

Salary:

132000.00 - 150000.00 USD / Year

Harry's

Expiration Date

Until further notice

Requirements

B.S. Chemistry or related science
3+ years of experience in a Regulatory Affairs position in cosmetic /personal care industries
Track record of executing cosmetic, OTC, and/or general product regulatory requirements in global markets
Track record of executing cosmetic regulatory requirements in global markets
Delivery and result focused, with high level of attention to detail and strong work ethic
High accuracy and reliability on assigned tasks
Demonstrated organizational agility - effective in working both independently and as part of a team with diverse groups of people at various levels within the organization
Excellent communication and organizational skills with the ability to meet project deadlines
Ability to function in a fast-paced environment
Demonstrates an immediate sense of urgency as well as flexibility

Job Responsibility

Oversee activities required for international and domestic compliance and registration to open and maintain market access, including import/export documentation, and all related activities
Lead regulatory intelligence and market entry strategy for new countries by researching and interpreting cosmetic regulations, registration pathways, labeling requirements, and ingredient restrictions to provide actionable guidance to cross-functional partners for successful product launches in new markets
Oversee drug product listing registration, annual renewals and establishment documents for all OTC products
Ensure all aspects of Regulatory compliance are reviewed and approved prior to market launch, working directly with cross functional teams (PD, R&D, Brand, Retail, Sourcing, PM). Scope includes: formulation, claims, packaging, artwork, registration, etc.
Work closely with third party partners and commercial teams to support international registrations
Assist in regulatory review of artwork for accuracy and compliance
Keep abreast of new Regulatory changes in all target markets globally and new product regulations and guidelines and ensure adherence throughout the product life cycle
Track new and upcoming regulatory changes for all target markets globally and present findings as needed to relevant cross functional departments
Verify documentation accuracy, consistency, and compliance
Assist with general product questions, regulatory inquiries, and questionnaires

What we offer

Medical, dental, and vision coverage
401k match
Equity in Mammoth Brands
Flexible time off and working hours
Wellness and L&D stipends
4 weeks sabbatical after 5 years, 6 weeks after 10 years, and 8 weeks after 15 years
20 fully paid weeks off for parents who give birth, or 16 fully paid weeks off for all other paths to parenthood
Fun IRL and virtual events including happy hours, team building events, and parties on our rooftop
Free products from all of our brands
Bagels on Wednesdays and lunch on Thursdays

Fulltime

Director, Regulatory Labeling

Beam is seeking a Director of Regulatory Affairs – Advertising, Labeling, and Pr...

Location

United States , Cambridge

Salary:

210000.00 - 260000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

BS required
an advanced degree (i.e. MS, PharmD, PhD, MD) is a plus
A minimum of 6 years of experience working in Regulatory Affairs Advertising, Labeling, and Promotion
ideally 15 plus years in the biotech industry with at least 8 years in regulatory affairs
Record of success with interactions with Regulatory Agencies and Health Authorities as part of label negotiations and label updates
Comprehensive knowledge of US and global regulatory procedures and practices
Extensive experience with regulatory documents and filings (IND, CTA/IMPD, BLA, MAA, PIP)
Strong strategic thinking and problem-solving skills
Experience in representing programs to internal and external stakeholders
Ability to develop collaborative working relationships internally as well as externally with physicians, expert consultants, and contracted vendors

Job Responsibility

Lead the creation, review, and approval of critical regulatory labeling documents including Core Data Sheet and Regional Labels for Beam hematology programs in alignment with Target Product Profiles
Lead labeling negotiations between Beam and health authorities as part of marketing authorization applications
Create regulatory labeling processes and associated SOPs, Work Instructions, and any other required documentation
Represent Regulatory Affairs as part of the Promotional Review Process
Incorporate the evolving global regulatory requirements and guidance's with respect to gene editing and gene therapy, rare disease, and prescription drug labeling
Provide innovative regulatory approaches, solutions and guidance to cross-functional teams while mitigating regulatory risks
Guide and assist on the planning, preparation, writing and submission of regulatory documentation
Manage project plans and timelines to ensure all projects are prioritized appropriately and milestones and goals are met on time
Provide regulatory due diligence as required
Supervise and mentor direct reports

Fulltime

Regulatory Affairs Specialist

Hemostasis, LLC designs, develops, manufactures, and markets advanced hemostat, ...

Location

United States , Saint Paul

Salary:

Not provided

Hemostasis Corp

Expiration Date

Until further notice

Requirements

Master’s degree in Regulatory Affairs and Services
Excellent written and oral communication skills
Demonstrate proactive and strategic thinking and be able to handle change and ambiguity

Job Responsibility

Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, and clarification/follow-up of submissions under review
Provide technical review of data or reports that will be incorporated into regulatory submissions
Analyze validation test data to determine whether systems or processes have met validation criteria
Study product characteristics or customer requirements and confer with management to determine validation objectives and standards
Identify deviations from established product or process standards and provide recommendations for resolving deviations
Develop validation master plans, process flow diagrams, test cases, and standard operating procedures
Create, populate and maintain the database for tracking validation activities, test results and validation systems
Prepare, maintain, and review validation and compliance documentation such as engineering change notices, schematics, and technical files to obtain and sustain product approval
Conduct audits of validation or performance qualification processes to ensure compliance with internal or regulatory requirements
Prepare additional information or responses as requested by regulatory agencies

What we offer

401K
Dental
Life
Medical
Disability
Competitive salary and benefits package including health, life, retirement and related benefits

Fulltime

Non-Pharma Global Regulatory Affairs Specialist

The Global Regulatory Non-Pharma Specialist manages regulatory documentation and...

Location

Italy , Bologna

Salary:

Not provided

Alfasigma

Expiration Date

Until further notice

Requirements

At least 5 years’ experience in Regulatory Affairs preferably within the food supplements, medical devices, and cosmetics sectors
Exposure to regulatory operations or documentation in EU and/or RoW markets or similar experiences is preferred
Advance degree in Life Sciences, Pharmacy, Chemistry, or a related field
Relevant certifications in Regulatory Affairs are considered a plus
Good knowledge of EU regulations for medical devices (MDR, MDD) and relevant legislation for food supplements and cosmetics
Strong attention to detail, time management and organizational skills
Willingness to learn and ability to work effectively in a team-based environment
Strong communication and interpersonal skills
Proficiency in Microsoft Office Suite and familiarity with document management systems
Fluent in English, both written and spoken

Job Responsibility

Contributing in a cross-functional team to provide the necessary regulatory input for the development of new projects
Support regulatory strategies by providing impact assessments
Collaborate actively with the Research & Development team to integrate regulatory requirements during the design and development of assigned products
Prepare, organize and submit regulatory documentation for submission and maintenance of dossiers for the projects assigned
Coordinate with local affiliates and global stakeholders to ensure submissions are aligned with timelines and business priorities
Manage multiple tasks in a fast-paced environment while keeping on task and to the company’s quality standards
Contribute to the preparation of regulatory project updates in internal meeting and governance committee providing regulatory input and flagging risks
Assist colleagues with administrative tasks
Execute defined regulatory tasks within scope and deadlines under the guidance of the Head
Review and validate commercial artwork, packaging, and labeling in compliance with EU Regulations, ensuring timely product launches

What we offer

Competitive salary
Comprehensive benefits
Extensive opportunities for professional growth and development

Japan Regulatory Strategy Group Senior Manager

The Japan Regulatory Strategy Group Sr Mgr is developing and executing the regul...

Location

Japan , Tokyo

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Bachelor’s degree and 15 years of directly related experience including 10+ years of experience in Regulatory Affairs
Communication skills in English (TOEIC score ≥860 desirable)
Native level Japanese
Computers: Microsoft Outlook, Word, Excel, Power Point, and communication tools
Ability to develop and lead effective teams
Ability to work in matrix environments including cross-functional and global teams
Ability to work under minimal direction with a medium degree of autonomy
Analytical skills to evaluate and interpret complex situations and problems
Ability to anticipate and prevent potential problems
Ability to independently develop solutions that are thorough, practical, and consistent with functional objectives

Job Responsibility

Develops and implements the Japan regulatory strategy
Provides guidance on local mechanisms to accelerate/optimize product development and regulatory approvals
Proactively influence developing the global regulatory strategy
Consistently look for opportunities to accelerate the developments/approval
Contributes to the filing plan by advising and discussing with the local and global cross-functional teams
Leads or oversees the preparation of regulatory submissions
Ensures that regulatory submissions are made on time and meet requirements
Collaborates with Clinical Study Operations teams to support local planning and execution for clinical studies
Ensures that local labels are developed and maintained
Proactively lead to develop regulatory strategies and/or mitigate regulatory risks

Fulltime

Manager, Regulatory Global Labeling

This position will be responsible for leading the development, review, and manag...

Location

United States , San Rafael

Salary:

108000.00 - 162000.00 USD / Year

BioMarin Pharmaceutical

Expiration Date

Until further notice

Requirements

4-6 years experience in the biopharmaceutical/biotechnology industry, or 2-4 years with Advanced Degree (Masters, PhD, MD)
2+ years in Regulatory Affairs
Regulatory Affairs experience is essential with direct experience managing labeling submissions and related activities
US and/or EU Labeling experience minimally required and core labeling experience highly desired
Experience and working knowledge with SPL and PLR requirements and/or SPC/PIL and QRD requirements
Excellent writing skills especially suitable for labeling, proven experience in drafting labeling content
Experience with E2E global labeling processes and management of Company Core Data Sheets
Experience in review process, standards, and industry best practice pertaining to labeling
Strong scientific background and/or experience
Working knowledge of medical terminology and drug safety

Job Responsibility

Lead the development, review, and management of US, EU, and International labeling for a product in development and commercial products
Assess and manage labeling changes for lifecycle products and develop new labeling for new products in pre-approval stages
Ensure appropriate labeling strategies are communicated to project teams
Ensure labeling is compliant with core labeling and local regulations
Ensure labeling is accurate and of the highest quality
Support implementation of approved labels which may include change management records, document control, QCing documents, translations and verification of translations, and tracking project milestones and status
Lead the assigned product labeling teams (PLTs) and support labeling positions
Collaborate with subject matter experts on the PLT, Global Regulatory sub-teams, and Senior Management Review Teams
Prepare labeling content based on source documents such as CSRs, regulatory requirements and other reference documents
Review worldwide labeling against the Core Safety Information and facilitate and track implementation of changes to align with core content

What we offer

Discretionary annual bonus
Discretionary stock-based long-term incentives
Paid time off
Company-sponsored medical, dental, vision, and life insurance plans

Fulltime

Regulatory Writing Senior Manager

In this key role you will serve as the functional area lead on product teams, le...

Location

United States

Salary:

152684.00 - 193308.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 2 years of directly related experience
Master’s degree and 6 years of directly related experience
Bachelor’s degree and 8 years of directly related experience
Associate’s degree and 10 years of directly related experience
High school diploma / GED and 12 years of directly related experience
Experience with regulatory documents in Regulatory Affairs, Research, Development or related area
5+ years of experience in medical writing in the Biotech/Pharmaceutical industry

Job Responsibility

Author or oversee the authoring of all regulatory submission documents including Clinical Study Reports, Investigator Brochures, Responses to Questions, Protocols, Protocol Amendments, Informed Consent Forms, Table of All Studies, Clinical Overview Addenda, eCTD Module 2 Clinical Summary Documents, Briefing Documents, and Pediatric Investigation Plans
Conduct the formal review and approval of authored documents, following applicable standard operating procedures
With limited supervision, lead regulatory writing activities for complex product submissions, including new and supplemental drug applications/biologics license applications
Serve as functional area lead on product teams (e.g., Global Regulatory Team, Evidence Generation Team, Global Safety Team, Label Working Group)
Provide functional area input for Global Regulatory Plan and team goals
Supervise the work of contract and freelance writers and mentor junior medical writers as assigned
Lead departmental and cross-departmental initiatives, as appropriate
Generate document timelines

What we offer

Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans and bi-annual company-wide shutdowns
Flexible work models, including remote work arrangements, where possible

Fulltime

Regulatory Affairs Labelling Manager

Proclinical

Location:
United Kingdom , Hertfordshire

Category:
IT - Administration

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
April 05, 2026

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Location:United Kingdom , Hertfordshire

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Job Description:

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Nice to have:

Additional Information:

Job Posted:April 05, 2026

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