Regulatory Affairs Manager Jobs

New

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

New

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 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

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 Senior Manager

Lead regulatory strategies and submissions for innovative oncology products in a...

Location

Japan , Tokyo

Salary:

8000000.00 - 12000000.00 JPY / Year

Randstad

Expiration Date

May 27, 2026

Requirements

Bachelor's degree or higher in life sciences, engineering, or a related field
8+ years of experience in regulatory affairs, with at least 3 years in IVD, genetic testing, precision medicine, or oncology
Proven experience in managing regulatory submissions to the PMDA
Strong understanding of Japanese regulatory requirements for medical devices and IVDs
Excellent communication skills in Japanese and English
Strong organizational and project management skills
Experience leading and mentoring teams
Experience with QMS and design control
Familiarity with genomic/molecular technologies
Experience negotiating with regulatory authorities

Job Responsibility

Lead the development and execution of regulatory strategies for new and existing products
Manage the preparation and submission of regulatory documents to the PMDA
Collaborate with cross-functional teams to ensure alignment on regulatory requirements
Monitor and interpret changes in regulatory landscape
Lead communication with PMDA/MHLW to ensure timely approvals
Identify and mitigate regulatory risks

What we offer

Health insurance
Employee pension insurance
Employment insurance
Saturdays off
Sundays off
Holidays off
Bonus
RSU

Fulltime

Quality Regulatory Manager

Quality Regulatory Manager position in Bengaluru, Karnataka requiring Master's d...

Location

India , Bengaluru

Salary:

Not provided

Randstad

Expiration Date

Until further notice

Requirements

Master's degree/Ph.D in Biomedical Engineering, Life Sciences, Biotechnology, or a related field
6-10 years of experience in regulatory affairs and quality management within the IVD or medical device industry
In-depth knowledge of global regulatory standards and quality management systems, including ISO 13485, ISO 14971, EU IVDR, US FDA 21 CFR 820, and CDSCO
Proven experience in leading regulatory submissions and successful product registrations

Fulltime

Director of Regulatory Affairs

ILIA is looking for a Director of Regulatory Affairs to join the team in buildin...

Location

United States , Laguna Beach; New York City

Salary:

160000.00 - 175000.00 USD / Year

ILIA Beauty

Expiration Date

Until further notice

Requirements

Minimum Bachelor’s degree in a relevant field (e.g., Life Sciences, Chemistry, Cosmetic Science, Regulatory Affairs)
10+ years of regulatory experience in the cosmetic or personal care industry, with at least 3 years in a managerial or leadership role
In-depth knowledge of U.S. and international cosmetic regulations (e.g., FDA, EU, Health Canada), safety assessment practices, and industry standards
Strong analytical and problem-solving skills, excellent written and verbal communication skills, and the ability to work collaboratively across departments, vendors and government agencies
Proven ability to lead and mentor a team of regulatory professionals, fostering a high-performance culture focused on compliance and innovation
Strong network within regulatory agencies and industry associations
Ability to work in a fast moving, fast changing environment
This position may require occasional travel to meet with regulatory agencies, attend industry conferences, or other related travel

Job Responsibility

Develop and implement a global regulatory strategy that aligns with business objectives while ensuring product compliance and safety (e.g. market expansion, short and long-term regulation updates, etc.)
Responsible for ensuring that all products comply with relevant regulations and standards (e.g., FDA, EU Cosmetic Regulation, etc.) throughout their lifecycle, from product development to marketing and distribution
Collaborate and communicate effectively with internal and external teams including but not limited to
product development, research and innovation, all marketing functions, and quality assurance, to ensure compliance with domestic and international regulations
Oversee the preparation and submission of regulatory documents, including ingredient notifications, safety assessments, and product registrations
Oversee post-market surveillance, adverse event reporting, and recall management
Collaborate with product development, marketing, quality assurance, and supply chain teams to provide regulatory advice and guidance during product formulation, testing, and labeling
Coordinate with product marketing, product development and testing facilities to create claims substantiation protocols and consumer perception questionnaires
Review product labels, marketing materials, and communications to ensure compliance with advertising regulations and truthful representation of product benefits
Contribute to the utilization & advancement of our product lifecycle management (PLM) tool or internal tools to manage global registrations, claims substantiation, and documentation workflows

What we offer

Bonus Opportunity
Health Benefits - 100% employer-paid medical, dental & vision coverage
Flex Time Off - No cap on personal time off and paid company holidays
Seasonal Flex Days - Flexible scheduling to enjoy extra time under the sun during the Spring & Summer season
Parental Leave - Up to 18 weeks paid parental leave
401(k) - Save for your future with a 401(k) with a company match
Flexibility & Wellness Stipends - Monthly stipends to support remote work & self-care
Hybrid Work Model - Find your flow, working from home or from one of our offices
ILIA Products - Quarterly stipend to replenish your favorite products and try new ones

Fulltime

Senior Regulatory Affairs Associate

As part of Parexel Consulting, you will play a vital role in helping biopharmace...

Location

India , Bengaluru

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Bachelor's Degree in Scientific or Technical Discipline
4+ years of experience in an industry-related environment
Project management knowledge
Client-focused approach
Results orientation
Teamwork and collaboration
Excellent interpersonal and intercultural communication
Critical thinking and problem-solving
Proficiency in local language and extensive English knowledge

Job Responsibility

Works effectively in teams or independently within area of competence
Works within project guidelines as directed by project/technical leads
Prioritizes work to achieve project outcomes
Seeks performance improvement and feedback
Applies information from senior colleagues to complete assigned activities
Produces quality work meeting project lead and client expectations
May serve as Project Lead for small projects or Work Stream Lead on larger projects
Functions as main client contact and ensures accurate project reporting
Ensures team delivery meets client expectations for quality and timeliness
Implements risk identification and issue-escalation procedures

What we offer

Flexible work arrangements
Opportunities for career growth
Supportive and inclusive environment
Diverse and global client exposure
Learn from experts

Regulatory Affairs Manager

Amgen

Location:
United Kingdom, Cambridge

Category:
-

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
December 18, 2025

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Pharmacovigilance and regulatory affairs manager BeNeLux