Regulatory Affairs Manager
About this opportunity
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.
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Job details
How this role compares
Computed from every other active Regulatory Affairs role in our database, not just this employer's listings.
We currently track 179 comparable Manager Regulatory Affairs roles across 64 biopharma companies.
Salary context
58 of 179 peers report a salary range (USD, annualized)
Peers share this role's job function and a matching or adjacent seniority level -- not necessarily the same therapeutic area or country.
Where these roles are based
Top locations among the 179 comparable roles
+ 21 more countries
Seniority mix
179 of 179 peers have a known seniority level
Therapeutic area mix
17 of 179 peers have a known therapeutic area; the rest are genuinely unlabeled, not hidden
Similar opportunities
The closest matches from our peer group, ranked by how similar they are, not how well you'd qualify for them -- treat this as market context, not a guaranteed shortlist; a weak match is labeled as one below.
Notify me about similar jobs
Get an email when we spot other openings like this one – same job function, comparable seniority, roles you'd actually want to see.
How we calculate "similar"
No black box, no LLM guesswork: a deterministic score built from four normalized attributes. Here's this role's own peer group at different match levels, so you can see the mechanism, not just the result.
Every comparison starts from the same 100-point budget: 25 for working in the same function, 40 for the same therapeutic area, 20 for the same or adjacent seniority, 15 for the same country. A dimension we can't confirm on both sides contributes nothing, never a guess, never a free pass.
0 points, never a partial guess. A role we know almost nothing about beyond its function bottoms out at 25%; it never inflates to 100% just because there's little to compare against. Seniority uses a defined ladder (Associate → Manager → Associate Director → Senior → Principal → Director → Senior Director → Executive/VP) so "Director" and "Senior Director" count as adjacent, but "Director" and "Executive/VP" do not.