Regulatory Affairs Manager
About this opportunity
Career Category
Regulatory
Job Description
Job Description
Applying, obtaining and maintaining regulatory approvals for products within Amgen’s portfolio, including CTN, MAA, renewal, variations of product’s life cycle management.
Ensure that regulatory submissions are made on time and meet Amgen corporate standards and local regulatory requirements.
Developing (with manager’s guidance) and implementing product related regulatory strategies, Regulatory Affairs processes and activity planning in accordance with national legislation and regulatory requirements
Undertake interactions and negotiations with Regulatory Authorities, to optimize regulatory approvals.
Participate in the local implementation of key Regulatory projects.
Maintains an awareness of new and developing legislation, regulatory policy and technical Regulatory guidance relating to Amgen pipeline.
Provide regulatory support for Therapeutic Areas/Scientific Affairs activities.
Where applicable, oversee external vendor/contractor relationships.
Feedback on any Regulatory Intelligence to International Regulatory Affairs
Knowledge and Skills
Regulatory expertise in national, MRP, centralized and biotechnology products, medical devices
Interactions with regulatory authorities
Working with policies, procedures and SOPs
Knowledge of national legislation and regulations relating to medicinal products
Understanding of the registration procedures in Europe and US for MAA, variations, extensions and renewals
Understanding of drug development
Experience managing regulatory processes
Scientific / Technical Excellence
Supervisory Skills
Communication Skills: Oral and Written
Team Work
Negotiation Skills
Ability to anticipate and prevent potential issues
Basic Qualifications
Doctorate degree
OR
Master’s degree and 3 years of directly related experience
OR
Bachelor’s degree and 5 years of directly related experience
OR
Associate’s degree and 10 years of directly related experience
Preferred Qualifications:
Experience in MNCs,
Experience in biologics
Experience in medical devices registration field
Multi-lingual
.
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 190 comparable Manager Regulatory Affairs roles across 63 biopharma companies.
Salary context
56 of 190 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 190 comparable roles
+ 25 more countries
Seniority mix
190 of 190 peers have a known seniority level
Therapeutic area mix
16 of 190 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.