Regulatory Affairs Sr Mgr
About this opportunity
Career Category
Regulatory
Job Description
Job Description
Apply, obtain and maintain regulatory approvals for products within Amgen’s portfolio, including CTNs, MAAs, renewals, variations, and other life cycle management activities.
Ensure all regulatory submissions are delivered on time and comply with Amgen corporate standards as well as local regulatory requirements.
Develop and implement product related regulatory strategies, Regulatory Affairs processes, and activity plans in accordance with national legislation and regulatory requirements
Lead interactions and negotiations with Regulatory Authorities to facilitate and optimize regulatory approvals.
Participate the in the local implementation of key Regulatory initiatives and projects.
Maintains an awareness of emerging legislation, regulatory policies, and technical Regulatory guidance relating to Amgen’s pipeline and product portfolio.
Provide regulatory support to Therapeutic Areas and Scientific Affairs activities.
Where applicable, oversee external vendors and contractors.
Feedback on relevant Regulatory Intelligence and insights to International Regulatory Affairs
Knowledge and Skills
Strong regulatory expertise in national, MRP, centralized procedures, biotechnology products, and medical devices
Proven experience in interacting with regulatory authorities
Solid understanding of policies, procedures and SOPs
In-depth knowledge of national legislation and regulations relating to medicinal products
Understanding of Europe and US regulatory pathways, including MAAs, variations, extensions, and renewals
Knowledge of drug development
Experience managing complex regulatory projects
Demonstrated scientific and technical expertise
Strong leadership
Excellent verbal and written communication skills
Effective team work and collaboration skills
Strong negotiation and stakeholder management abilities
Ability to proactively identify, anticipate, and mitigate potential issues
Basic Qualifications
Doctorate degree and a minimum of 5 years of directly related experience; or
Master’s degree and a minimum of 8 years of directly related experience; or
Bachelor’s degree and a minimum of 12 years of directly related experience
Preferred Qualifications:
Experience working in MNCs,
Experience in Biologics
Experience in Oncology
Experience in medical devices registration field
Proficiency in multiple languages
.
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 88 comparable Senior Regulatory Affairs roles across 39 biopharma companies.
Salary context
38 of 88 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 88 comparable roles
+ 12 more countries
Seniority mix
88 of 88 peers have a known seniority level
Therapeutic area mix
6 of 88 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.