Regulatory Affairs & Safety Manager Job at Life Science Talent (Søborg)

Pharmacovigilance and regulatory affairs manager BeNeLux

Responsible for overseeing Regulatory affairs and Pharmacovigilance activities a...

Location

Netherlands , Utrecht

Salary:

Not provided

Alfasigma

Expiration Date

Until further notice

Requirements

Minimum 5-10 years of experience in regulatory affairs and pharmacovigilance within pharmaceutical company
Knowledge of local pharmaceutical legislation for Regulatory in the BeNeLux region
Knowledge of applicable laws and regulations to ensure full compliance
Knowledge of Regulatory affairs and Pharmacovigilance activities (act as primary contact for regulatory authorities and for external consultants in the regions, ensuring compliance of Product Information, API, approval of artworks for packaging materials and implementation of aRMM)
Proficiency in speaking, comprehending, reading and writing Dutch is required
Proficiency in speaking, comprehending, reading and writing English is required
Ability to think strategically & execute tactically

Job Responsibility

Act as local single point of contact for global functions in Regulatory Affairs and Pharmacovigilance for the BeNeLux
Act as the Local Safety Officer (LSO) for the Netherlands, Belgium and Luxembourg
Act as primary contact for regulatory authorities and for external consultants, ensuring compliance of Product Information, approval of artworks for packaging materials and implementation of aRMM
Responsible for creating and keep the local Regulatory affairs and Pharmacovigilance SOPs up to date
Responsible for training of BeNeLux team in local Regulatory affairs and Pharmacovigilance SOPs
Work closely together with Pharmacovigilance and regulatory affairs managers within the BNS cluster (BeNeLux Nordics and Switzerland) creating a network of knowledge and international cooperation and support
Collaborate with commercial, medical and market access to realize cross-functional objectives

What we offer

Competitive salary and benefits package
Opportunities for professional growth and development

Non-Pharma Global Regulatory Affairs Manager

The Global Regulatory Sciences-Legacy Products-Non-Pharma Manager manages regula...

Location

Italy , Bologna; Milano; Pomezia

Salary:

Not provided

Alfasigma

Expiration Date

Until further notice

Requirements

Proven experience in Regulatory Affairs within the pharmaceutical or life sciences industry, preferably within the food supplements, medical devices, and cosmetics sectors
Hands-on experience with regulatory submission processes, especially within EU and/or RoW markets or similar relevant experiences
Demonstrated ability to coordinate projects or deliverables with complexity and limited supervision
Advanced degree in Life Sciences, Pharmacy, Chemistry, or a related field
Good knowledge of global regulatory frameworks including EU regulations for medical devices (MDR, MDD) and relevant legislation for food supplements and cosmetics
Strong organizational skills, attention to detail, and ability to manage priorities
Collaborative mindset and effective communication with team members and stakeholders
Ability to operate independently on clearly defined assignments
Proficiency in Microsoft Office Suite and regulatory submission/document management tools
Fluent in English, both written and spoken

Job Responsibility

Accountable for providing the necessary regulatory inputs in a cross-functional team for the development of new projects
Accountable for the execution and implementation of global regulatory strategies by managing day-to-day activities for assigned products
Manage multiple regulatory workstreams independently, including authoring, reviewing and coordinating documentation for regulatory submissions such as variations, renewals and geo-expansions
Provide and review regulatory assessments for change controls and product updates
Responsible for the preparation, review and collection of documentation for submission and maintenance of Technical File and PTD for the project assigned
Provide critical review of documentation supporting regulatory applications
Coordinate with local affiliates and global stakeholders to ensure submissions are aligned with timelines and business priorities
Contribute to the preparation and presentation of regulatory project updates in internal meetings and governance committees
Execute defined regulatory tasks within scope and deadlines under the guidance of the Head
Support other relevant assignments as directed by supervisor

What we offer

Competitive salary
Comprehensive benefits
Extensive opportunities for professional growth and development

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

Director of Safety and Quality

Merlin is a venture backed aerospace startup building a non-human pilot to enabl...

Location

United States

Salary:

Not provided

Merlin Labs

Expiration Date

Until further notice

Requirements

10+ years of experience leading complex safety, regulatory, and compliance projects in a technology company, startup, or government agency
Proven ability to build relationships with senior leaders in government, industry, and academia
Strong organizational skills with exceptional attention to detail
Ability to remain calm and decisive in high-pressure situations
Capable of working independently and collaboratively within a team

Job Responsibility

Leadership and Strategy: Report to the CEO, overseeing the development and execution of short- and long-term safety and regulatory strategies, plans, and resources
SMS and QMS Leadership: Lead the integration and continuous improvement of Safety Management Systems and Quality Management Systems across the entire business, ensuring compliance with international standards and regulations
Cross-Functional Collaboration: Work closely with certification, compliance, regulatory, and engineering teams on technology projects, and manage the program management process for obtaining approvals for autonomous technology from global regulatory agencies such as FAA, NASA, Department of Transportation, Department of Defense, ICAO, and EASA
Consultant Management: Coordinate with a roster of external consultants and experts to ensure their seamless integration into Merlin's programs, maximizing their impact as force multipliers
Program and Project Management: Oversee the selection and administration of project tracking tools, optimizing program management across global policy, compliance, safety, and regulatory affairs teams
Team Development and Standards: Foster a culture of excellence by developing work standards and guidelines for the team, ensuring adherence to established procedures, processes, and compliance standards
Relationship Building: Identify, track, and manage critical regulatory, policy, and industry relationships both domestically and internationally, in collaboration with business development and company leads

What we offer

health
dental
life
unlimited vacation
401k with match

Fulltime

Regulatory Specialist

At 2San, we are at the forefront of innovation in the global healthcare industry...

Location

United States , Norwood

Salary:

80000.00 USD / Year

2San

Expiration Date

Until further notice

Requirements

Proven regulatory affairs experience within the healthcare sector, with a focus on Class 2 and Class 3 Self-Test IVDs
Deep understanding of regulatory requirements and processes for the US market, including 510(k) management, FDA submissions, and compliance management
Experience with developing, implementing, and managing Quality Management Systems (QMS) in accordance with US and international standards, including familiarity with ISO 13485
Ability to develop and implement regulatory strategies that align with company objectives and product lifecycle
Strong analytical skills for assessing regulatory compliance, interpreting guidelines, and resolving complex issues
Excellent written and verbal communication skills for effective liaising with regulatory bodies, internal teams, and external partners
Proactive in identifying potential regulatory obstacles and developing effective solutions
Meticulous attention to detail with the capability to manage multiple projects and priorities simultaneously
Bachelor’s degree in a relevant scientific discipline (e.g., Biology, Chemistry, Biomedical Engineering) required
advanced degrees or certifications in regulatory affairs or quality assurance preferred

Job Responsibility

Monitoring and management of new and existing 510(k) entries to ensure all product listings are current and compliant with regulatory requirements
Preparing and submitting FDA applications for new product approvals and amendments for existing products, ensuring all submissions are accurate and meet regulatory standards
Maintaining the regulatory tracker to ensure all information is current and in-line with local requirements
Maintaining regular contact with manufacturers for products supplier in US. Ensuring that their conformity assessment is not due to lapse and ensuring that a plan is in place for updated certification. (IVDD to IVDR)
Regularly reviewing and updating the Quality Management System (QMS) to ensure it aligns with both US and international standards, including ISO 13485, and addressing any gaps or non-compliances
Overseeing Complaints Management and Post-Market Surveillance Activities, including the collection, analysis, and reporting of customer feedback and adverse events to regulatory bodies as required. Implementing corrective actions and ensuring continuous product quality and safety monitoring in compliance with regulatory requirements
Collaborating with product development teams to provide regulatory guidance and support from concept through to commercialization, ensuring regulatory considerations are integrated into product lifecycle management
Navigating regulatory pathways to secure product approval and market entry, including strategizing for efficient and compliant product launches
Applying strong analytical skills to assess regulatory compliance, interpret complex regulatory guidelines, and undertake risk assessments for regulatory strategies and submissions
Proactively identifying potential regulatory challenges and obstacles and working collaboratively with cross-functional teams to develop and implement effective solutions

Regulatory Affairs Manager

Cencora Pharmalex is one of the leading service providers for the Pharmaceutical...

Location

Vietnam , Remote

Salary:

Not provided

Cencora

Expiration Date

Until further notice

Requirements

Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or a related field
Minimum of 5 years’ experience working in regulatory affairs within the pharmaceutical or healthcare industry or in a consulting setting
Excellent project management and stakeholder engagement skills
Ability to work independently and in a fast-paced consulting environment
Ability to effectively project manage and deliver several projects at once

Job Responsibility

Regulatory Affairs activities for lifecycle management of pharmaceutical products
Support change applications (Administrative, Labelling, Chemistry Manufacturing & Controls, Safety) including submission strategy
Dossier compilation including preparation of documents (e.g. local forms, Cover Letters) and Table of Contents
Content review of Chemistry, Manufacturing & Controls/Labelling documentation/Justification documents
Alignment with functions on variation procedures, deficiency letter, e.g, Chemistry Manufacturing Controls, Medical Science, publishing team
Update/local Product Information (Labelling translation)
Check regulatory compliance of product information/artworks
Marketing Authorization withdrawal
Marketing Authorization Holder transfer
Licence renewal

Fulltime

Regulatory & Compliance Manager – Colour Cosmetics & Skincare

The role of Regulatory & Compliance Manager – Colour Cosmetics & Skincare

Location

United Kingdom , Cheshire

Salary:

Not provided

Beautiful Recruitment

Expiration Date

Until further notice

Requirements

A minimum of 5+ years’ experience as a Regulatory Manager, Regulatory Team Leader, Regulatory & Compliance Manager, or, Regulatory Affairs Manager in the Cosmetics/Skincare/Haircare/Fragrance/Personal Care sector
Ideally EU or global reach
Calm under pressure and able to balance often conflicting priorities
An experienced regulatory people leader with a proven track record of developing results-driven regulatory teams
Someone who loves to train and mentor others in regulatory affairs
Have a good addition to detail and strong communication skills

Job Responsibility

Lead and manage a team of regulatory professionals, ensuring all training and personal developments are met
Develop, implement and update processes for improvement to ensure ongoing compliance with the relevant regulations and standards
Ensuring all regulatory policies and processes are in place to deliver compliant global products. This includes the development and maintenance of Cosmetic Product Information Files (PIFs), claims substantiation and the management of Cosmetic Product Safety Reports (CPSRs)
Ensure all customer requirements are met. This includes the requirements of
The Vegan Society, Cruelty-Free International (CFI) and Round Table for Sustainable Palm Oil (RSPO)
Managing an effective global regulatory horizon scanning process to ensure our client’s regulatory processes remain future fit

What we offer

Highly Competitive Base Salary DOE
Discretionary Bonus
Private Healthcare
Pension
Free Parking
25 Days Holiday + 8 Bank Holidays + Day off for Birthday
Early finish Friday

Fulltime

Regulatory Affairs Manager

Cencora Pharmalex is one of the leading service providers for the Pharmaceutical...

Location

Indonesia

Salary:

Not provided

Cencora

Expiration Date

Until further notice

Requirements

Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or a related field
Minimum of 5 years’ experience working in regulatory affairs within the pharmaceutical or healthcare industry or in a consulting setting
Excellent project management and stakeholder engagement skills
Ability to work independently and in a fast-paced consulting environment
Ability to effectively project manage and deliver several projects at once

Job Responsibility

Regulatory Affairs activities for lifecycle management of pharmaceutical products
Support change applications (Administrative, Labelling, Chemistry, Manufacturing & Controls, Safety) including submission strategy
Dossier compilation including preparation of documents (e.g. local forms, Cover Letters) and Table of Contents
Content review of Chemistry, Manufacturing & Controls/Labelling documentation/Justification documents
Alignment with functions on variation procedures, deficiency letter, e.g, Chemistry Manufacturing Controls, Medical Science, publishing team
Update/local Production Information (Labelling translation)
Check regulatory compliance of product information/artworks
Marketing Authorization withdrawal
Marketing Authorization Holder transfer
Licence renewal

Fulltime

Regulatory Affairs & Safety Manager

Life Science Talent

Location:
Denmark , Søborg

Category:
Research and Development

Contract Type:
Employment contract

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
April 11, 2026

Looking for more opportunities? Search for other job offers that match your skills and interests.

Similar Jobs for Regulatory Affairs & Safety Manager

Pharmacovigilance and regulatory affairs manager BeNeLux