Manager Regulatory Affairs Jobs

New

Senior Manager, Regulatory Affairs & Quality Assurance, APAC

Provide strategic Regulatory Affairs and Quality leadership for all APAC markets...

Location

Singapore

Salary:

Not provided

Avanos

Expiration Date

Until further notice

Requirements

Bachelor’s degree in a relevant scientific or technical discipline
6-10 years of experience in the medical device industry
Proven leadership experience with a track record in managing teams and developing long-term strategic initiatives
Strong written and verbal communication skills
Experience with regional or international regulatory submissions preferred
Strong computer proficiency
Understanding of regulatory requirements across major APAC markets
Familiarity with mandatory Quality Management System requirements across APAC
General knowledge of US FDA regulations (21 CFR, FDA guidelines) and EU CE marking processes is an advantage

Job Responsibility

Provide strategic Regulatory Affairs and Quality leadership for all APAC markets where Avanos operates
Partner with global and regional stakeholders to ensure full compliance with regulatory requirements, support business objectives, and strengthen the RA/QA capability across the region
Serve as an active member of the Global Regulatory & Clinical Affairs, Global Quality, and APAC Leadership Teams
Provide Regulatory and Quality leadership across all APAC markets
Recruit, build, and develop in-country RA/QA teams
Advise APAC cross-functional teams and Global RA & Clinical Affairs and Global Quality functions on regional regulatory requirements
Oversee the preparation, submission, and lifecycle maintenance of product registrations across APAC
Maintain regulatory databases
Direct the development and maintenance of regulatory systems and processes
Develop APAC regulatory strategies

What we offer

comprehensive and competitive range of benefits
health care benefits
retirement plans
work/life benefits

New

Regulatory Affairs Manager

In this vital role you will work to ensure that Amgen acquires and maintains all...

Location

United Kingdom , Cambridge

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Scientific Degree and demonstrated experience in a similar role
Regulatory principles
Working with policies, procedures and SOP’s
Knowledge of legislation and regulations relating to medicinal products
Awareness of the registration procedures in region for clinical trials, MA, post approval changes, extensions and renewals.
Knowledge of drug development
Knowledge of and experience in regional regulatory environment
Strong communication skills - both oral and written
Ability to understand and communicate scientific/clinical information
Ability to anticipate and prevent potential issues

Job Responsibility

Plan and manage regulatory submissions (e.g. clinical trial and marketing applications) for products within Amgen's portfolio in compliance with global filing plans and local regulatory requirements.
Under general supervision, implement product related regulatory strategies, Regulatory Affairs processes and activity planning in accordance with national legislation and regulatory requirements.
Provide content guidance for regional regulatory documents and meetings in accordance with global strategy
Provide regulatory guidance on regional regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, Fast Track, compassionate use and paediatric plans)
Support regional label negotiation activities
Under general supervision participate in the development, and execution of regional regulatory product strategies
Under general supervision, develop predictions for expectations and risks associated with outcomes by regulatory agencies
Maintain an awareness of new and developing legislation, regulatory policy and technical Regulatory guidance relating to Amgen products.
Perform regulatory research to obtain relevant histories, precedence and other information relevant to regional product advancement.
Under supervision evaluate and communicate impact of relevant regional regulations, guidances, current regulatory environment and competitor labelling

What we offer

Growth opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Fulltime

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 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

Manager Regulatory Affairs

Beam Therapeutics

Location:
United States , Cambridge

Category:
Research and Development

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
December 24, 2025

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