CrawlJobs Logo

Regulatory Affairs Manager

https://www.randstad.com Logo

Randstad

Location Icon

Location:
Germany , Ludwigshafen am Rhein

Category Icon
Category:
IT - Administration

Job Type Icon

Contract Type:
Not provided

Salary Icon

Salary:

45000.00 - 60000.00 EUR / Year
Save Job
Save Icon
Apply Position

Job Description:

Time for change – time for a new job! You are a regulatory affairs specialist and looking for a new professional challenge? Then stop searching! We offer the job you are looking for: Our subsidiary Randstad professional solutions offers a secure job, fair compensation and exciting new tasks at an attractive pharmaceutical company in Ludwigshafen. Apply online now! We welcome applications from all suitably qualified persons regardless of any disabilities.

Requirements:

  • Bachelor's degree in life science, clinical research studies or engineering, ideally with previous regulatory experience
  • Several years of experience in a regulated business environment (e.g. legal office, regulated industry)
  • Experience working with Microsoft Office suite, most notably with Excel, Word, Outlook, Teams, and Microsoft SharePoint tools
  • Working knowledge of database management
  • Knowledge on current policies and practices issued by local German federal agencies
  • Awareness on regulatory policies/procedures to learn and better understand how the landscape of regulations develops
  • Good proficiency in the English language
  • Strong negotiation and communication skills as well as ability to organize data and identify issues or gaps in documentation

Additional Information:

Job Posted:
May 17, 2026

Expiration:
June 30, 2026

Employment Type:
Fulltime
Work Type:
On-site work
Icon
Randstad - All Job Offers
Job Link Share:
Copy Link Icon
Facebook Icon Twitter Icon LinkedIn Icon

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

Briefcase Icon

Similar Jobs for Regulatory Affairs Manager

Quality & Regulatory Affairs Manager

We’re looking for a Quality & Regulatory Affairs Manager who’s passionate about ...
Location
Location
United States; Canada , Boston; Chicago; Ottawa; Toronto
Salary
Salary:
Not provided
fullscript.com Logo
Fullscript
Expiration Date
Until further notice
Flip Icon
Requirements
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
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
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
Read More
Arrow Right

Regulatory Affairs Manager

As an active member of the Regulatory Affairs team, this position will participa...
Location
Location
United States , New York
Salary
Salary:
132000.00 - 150000.00 USD / Year
harrys.com Logo
Harry's
Expiration Date
Until further notice
Flip Icon
Requirements
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
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
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
Read More
Arrow Right

Pharmacovigilance and regulatory affairs manager BeNeLux

Responsible for overseeing Regulatory affairs and Pharmacovigilance activities a...
Location
Location
Netherlands , Utrecht
Salary
Salary:
Not provided
it.alfasigma.com Logo
Alfasigma
Expiration Date
Until further notice
Flip Icon
Requirements
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
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
What we offer
  • Competitive salary and benefits package
  • Opportunities for professional growth and development
Read More
Arrow Right

Non-Pharma Global Regulatory Affairs Manager

The Global Regulatory Sciences-Legacy Products-Non-Pharma Manager manages regula...
Location
Location
Italy , Bologna; Milano; Pomezia
Salary
Salary:
Not provided
it.alfasigma.com Logo
Alfasigma
Expiration Date
Until further notice
Flip Icon
Requirements
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
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
What we offer
  • Competitive salary
  • Comprehensive benefits
  • Extensive opportunities for professional growth and development
Read More
Arrow Right

Senior Manager, Regulatory Affairs & Quality Assurance, APAC

Provide strategic Regulatory Affairs and Quality leadership for all APAC markets...
Location
Location
Singapore
Salary
Salary:
Not provided
avanos.com Logo
Avanos
Expiration Date
Until further notice
Flip Icon
Requirements
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
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
What we offer
  • comprehensive and competitive range of benefits
  • health care benefits
  • retirement plans
  • work/life benefits
Read More
Arrow Right

Manager Regulatory Affairs

Beam is seeking a Manager Regulatory Affairs to progress a broad portfolio of ad...
Location
Location
United States , Cambridge
Salary
Salary:
125000.00 - 155000.00 USD / Year
beamtx.com Logo
Beam Therapeutics
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • BS in a medical or scientific field required
  • Strong grasp of drug development lifecycle and strategy
  • A minimum of 8 years of experience working in Regulatory Affairs
  • Knowledge of US and global regulatory procedures and practices
  • Firsthand experience with regulatory document authoring and submission (e.g. IND, CTA, BLA, MAA, PIP)
  • Experience supporting teams through interactions with Regulatory Agencies and Health Authorities
  • Ability to develop and maintain collaborative working relationships with internal and external partners
  • Excellent written/verbal communication skills, attention to detail, organizational skills
Job Responsibility
Job Responsibility
  • drive the development of global regulatory strategy for Beam’s portfolio of advanced genetic medicines
  • Incorporate evolving global regulatory requirements and guidance's with respect to gene editing and gene therapy, rare disease, orphan indications, breakthrough treatments and other relevant regulations
  • Maintain and update regulatory submission plans, timelines, and other core strategic documents
  • represent Regulatory Affairs on cross functional and project teams
  • 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
  • Fulltime
Read More
Arrow Right

Regulatory Affairs Manager

The RA Manager supports Global Reg Teams in the development and execution of glo...
Location
Location
United States
Salary
Salary:
51.00 - 75.00 USD / Hour
biomarin.com Logo
BioMarin Pharmaceutical
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Degree in health or life sciences, including chemistry, molecular biology, or similar. PhD preferred, Masters/Bachelors acceptable with relevant experience
  • 4+ year experience
  • Nonclinical / Clinical Regulatory Affairs experience preferred
Job Responsibility
Job Responsibility
  • Support the development of the nonclinical / clinical regulatory strategy and plan
  • Assist with selected planning, document development and meeting execution activities in preparation for HA meetings / interactions
  • Participate in Study Execution Teams for assigned products and identify relevant regulatory considerations for discussion with RNC Lead
  • Collaborate with CROs that are contracted to perform regulatory submissions/HA interactions for global clinical trials
  • With oversight by RNC lead, develop and coordinate the core nonclinical / clinical content of regulatory submissions
  • Responsible for ensuring high quality nonclinical/clinical content that adheres to regulations and guidances
  • Lead the maintenance of IND/CTAs throughout the life of the studies (e.g., annual reports)
  • Assist with the preparation of HA submission packages including but not limited to compiling relevant materials (Protocols, Annual Reports, Briefing Books, etc.) and completing regulatory documents/forms for internal review
  • Collaborate with Reg PM to create and align submission timelines
  • Collaborate with Reg Ops to provide final documents and QC published outputs for submissions to HA
What we offer
What we offer
  • discretionary annual bonus
  • discretionary stock-based long-term incentives
  • paid time off
  • company-sponsored medical, dental, vision, and life insurance plans
Read More
Arrow Right

Regulatory Affairs Senior Manager

Lead regulatory strategies and submissions for innovative oncology products in a...
Location
Location
Japan , Tokyo
Salary
Salary:
8000000.00 - 12000000.00 JPY / Year
https://www.randstad.com Logo
Randstad
Expiration Date
May 27, 2026
Flip Icon
Requirements
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
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
What we offer
  • Health insurance
  • Employee pension insurance
  • Employment insurance
  • Saturdays off
  • Sundays off
  • Holidays off
  • Bonus
  • RSU
  • Fulltime
Read More
Arrow Right