[Skip to main content](#main-content)

[ OpenNash ](https://opennash.com/) / [Jobs](https://jobs.opennash.com/) [ 01 Search jobs](https://jobs.opennash.com/search/)[ 02 Companies](https://jobs.opennash.com/explore/)[ 03 Hiring report](https://jobs.opennash.com/reports/hiring/)[ 04 AI assistants](https://jobs.opennash.com/connect/)[ 05 How it works](https://jobs.opennash.com/methodology/)

Amgen · Netherlands - Breda

# Regulatory Affairs Manager

Netherlands - Breda Manager or lead Legal & Compliance 

Listed on Amgen’s official careers site. Posted October 28, 2026. Check that it is still open and apply there.
[Apply on Amgen’s careers site →](https://amgen.wd1.myworkdayjobs.com/Careers/job/Netherlands---Breda/Regulatory-Affairs-Manager_R-251047)

[OpenNash Jobs](https://jobs.opennash.com/) / [Amgen](https://jobs.opennash.com/companies/amgen/) / Regulatory Affairs Manager

## Job description

Career Category Regulatory

### Job Description

If you feel like you’re part of something bigger, it’s because you are. At Amgen our shared mission—to serve patients—drives all that we do. It is key to becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.

Join us as: REGULATORY AFFAIRS MANAGER At Amgen Breda medicines are labelled, assembled, stored and eventually shipped to various countries worldwide. Every day more than 1000 people with 42 different nationalities are working on supply chain processes, manufacturing, marketing and sales of our medicines and clinical research into new medicines. LIVE What you will do In this vital role you will provide expertise in translating chemistry, manufacturing and control (CMC) regulatory requirements into practical, workable plans.

The primary responsibilities of this role are to support the planning and execution of the site-specific aspects of the preparation of CMC sections for new marketing applications, and post-market supplements and preparation CMC sections of annual reports of minor changes for specific products. You will also act as key Regulatory Affairs (RA)-CMC representative for managing change control, deviations and serve as the point of contact for communications with business partners and global regulatory authorities for requests related to the site.

Specific responsibilities include but are not limited to: Support the develop and implementation of regulatory strategies as they relate to changes at the site. Lead submission process for site initiatives Provide strategic expertise regarding regulatory requirements for manufacturing related projects. Collaborate with Regulatory Authorities as appropriate and in coordination with Global and International representatives.

Support regulatory authority inspections as required by Site Quality Compliance. Serve as RA - CMC representative on Cross Functional Teams. Lead or collaborate in the creation site related regulatory components for global submissions. Support the generation of facility and GMP related documents to be used in product registrations activities. Review and approve regulatory documents. Review and assess the regulatory impact of proposed manufacturing related changes, deviations and other GMP related documents.

Maintain facility related files. Develop and maintain regulatory awareness through meetings, conferences and regulatory contacts. WIN What we expect of you We are all different, yet we all use our unique contributions to serve patients. The Regulatory Affairs Manager professional we seek is a strong leader with these qualifications.

Doctorate degree / Master’s degree and 3 years of Quality, Process Development, Validations and/or Regulatory Affairs experience in Pharmaceutical/Biotech industry OR Bachelor’s degree and at least
- 5 years of Quality, Process Development, Validations and/or Regulatory Affairs experience in Pharmaceutical/Biotech industry Educational background in Biology, Biotechnology, Microbiology or Chemistry Experience managing change control and regulatory submissions
- Strong oral and written communication skills in English and Dutch
- Strong negotiating and leadership skills Experience managing project timelines is desirable
- Proficiency working with teams at different levels and company locations Able to operate in a fast paced, dynamic environment THRIVE What you can expect of us As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.

Therefore, Amgen is regularly recognized as a Best Place To Work ©. Vast 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 competitive salary, bonus structure, fixed 13th month, holiday allowance and a collective health insurance. Focus on vitality with an on-site gym, vitality prog ram and a restaurant with healthy food..

## At a glance
- Posted by the employer: Oct 28, 2026
- First seen by OpenNash: Aug 21, 2026
- Last checked: Nov 1, 2026
- Listed for: 72 days
- Location: Netherlands - Breda[Apply on Amgen’s careers site →](https://amgen.wd1.myworkdayjobs.com/Careers/job/Netherlands---Breda/Regulatory-Affairs-Manager_R-251047)

## Hiring at Amgen
- Open jobs: 1,989
- New in the last 7 days: After two weekly collections
- Tracked since: Jul 10, 2026

[All Amgen jobs](https://jobs.opennash.com/companies/amgen/) · [Weekly hiring report](/reports/hiring/)

## More jobs at Amgen

### [Digital Engagement Manager](https://jobs.opennash.com/companies/amgen/jobs/0291feaad4096e494880/)

Netherlands - Breda

### [Lead Technician Utilities](https://jobs.opennash.com/companies/amgen/jobs/64f287a53b5aaea1d72d/)

Netherlands - Breda

### [Line Lead Manufacturing (Multiple Openings)](https://jobs.opennash.com/companies/amgen/jobs/7fad6e4f7a8cad132f79/)

Netherlands - Breda

### [Manager Manufacturing](https://jobs.opennash.com/companies/amgen/jobs/a659e43c125289926f0b/)

Netherlands - Breda

### [Manager QA](https://jobs.opennash.com/companies/amgen/jobs/8470caca358c630d7c0a/)

Netherlands - Breda

## Similar jobs at other companies

### [Regulatory Affairs Manager, Oncology Therapeutic Group, Global Regulatory Affairs](https://jobs.opennash.com/companies/gsk/jobs/09fdd8d7e12226e3ad65/)

GSK · London, United Kingdom

### [Senior Regulatory Specialist I - Toxicology, Global Regulatory Affairs](https://jobs.opennash.com/companies/ecolab/jobs/a7f265c77c592a38c347/)

Ecolab · Pune, Mahārāshtra, India

### [Regulatory Affairs Specialist](https://jobs.opennash.com/companies/ecolab/jobs/2f207cd244cb549328ab/)

Ecolab · Kraków, Poland

### [Principal Regulatory Affairs Professional](https://jobs.opennash.com/companies/thermo-fisher-scientific/jobs/3a8ef8a0559f4968a312/)

Thermo Fisher Scientific · Remote, Mexico

### [Regulatory Affairs Specialist](https://jobs.opennash.com/companies/thermo-fisher-scientific/jobs/c80907ca1d5f566fcec5/)

Thermo Fisher Scientific · Bangalore, Karnātaka, India

OpenNash lists jobs from employers’ own careers sites and does not handle applications.
Dates come from the employer where stated; “first seen” and “last checked” are our own observations.

[ OpenNash ](https://opennash.com/)

AI-native services firm that builds custom software and 24/7 AI agents.

OpenNash Jobs is an OpenNash Applied AI project.
[Book time with OpenNash](https://calendly.com/opennash/new-meeting?hide_gdpr_banner=1)

Jobs
- [Search jobs](https://jobs.opennash.com/search/)
- [Companies](https://jobs.opennash.com/explore/)
- [Hiring report](https://jobs.opennash.com/reports/hiring/)
- [AI assistants](https://jobs.opennash.com/connect/)
- [How it works](https://jobs.opennash.com/methodology/)

OpenNash
- [opennash.com](https://opennash.com/)
- [Services](https://opennash.com/ai-agent-consulting/)
- [OpenNash CX](https://opennash.com/cx/)
- [AI Tools](https://opennash.com/ai-tools/)
- [Blog](https://opennash.com/blog/)
- [About](https://opennash.com/about/)

Contact
- [hello@opennash.com](mailto:hello@opennash.com)

- [LinkedIn](https://www.linkedin.com/company/opennash)

- [Support](https://jobs.opennash.com/support/)

- [Privacy](https://jobs.opennash.com/privacy/)

- [Terms](https://jobs.opennash.com/terms/)

© 2026 OpenNash, Inc. Company names and public job postings belong to their respective owners. Employers control source availability and application decisions.