Manager - Registration Management
About this opportunity
Role Purpose
Provide strategic and operational leadership for Regulatory Information Management (RIMs) to ensure accurate, compliant, and timely management of global regulatory data, product lifecycle activities, and inspection readiness.
Key Responsibilities
Lead and develop a high‑performing RIMs team to deliver seamless day‑to‑day regulatory operations.
Oversee creation and maintenance of regulatory applications for NPIs, safety variations, and lifecycle activities.
Provide subject‑matter expertise and operational support for regulatory activities managed within centralized RIMs systems.
Manage workflows for timely delivery of critical regulatory reports (e.g., Status, Product Quality, WWMAS) supporting supply, manufacturing, PV inspections, and governance.
Own XeVMPD submissions and ongoing maintenance of registered product data.
Ensure accuracy, integrity, and completeness of registered product and master data across global markets (LATAM, METAP, APAC, EU, India, and others).
Maintain and update SOPs and Work Instructions for assigned workstreams, ensuring continuous audit and inspection readiness.
Support regulatory audits and health authority inspections through RIMs expertise, data extraction, and documentation.
Lead User Acceptance Testing (UAT) and related testing for new features, system enhancements, or major RIMs implementations.
Drive continuous improvement, data quality excellence, and compliance with global regulatory requirements.
Manage team performance, capability building, and career development.
Required Expertise
Strong knowledge of global regulatory regulations and guidelines.
Hands‑on experience with industry‑standard RIMs tools and regulatory systems.
Proven people leadership and stakeholder management capability.
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 227 comparable Manager Regulatory Affairs roles across 71 biopharma companies.
Salary context
68 of 227 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 227 comparable roles
+ 24 more countries
Seniority mix
227 of 227 peers have a known seniority level
Therapeutic area mix
19 of 227 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.
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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.