Associate - CSCC & RM
About this opportunity
Associate – Registration Management & CSCC (Certificate and samples coordination center)
Support and administer Regulatory Information Management (RIM) systems to ensure accurate, compliant, and reliable regulatory data.
Track global regulatory submissions, approvals, commitments, and product lifecycle activities within the RIM platform.
Partner with Regulatory Affairs, Pharmacovigilance, affiliates, and cross-functional teams to maintain data quality and transparency.
Support system enhancements, upgrades, testing, validation, and user acceptance testing (UAT) activities.
Troubleshoot and resolve RIM system and data-related issues to ensure business continuity.
Support the implementation and maintenance of regulatory data standards, processes, and governance practices.
Assist with regulatory compliance activities, including audit/inspection readiness, documentation, and reporting.
Support safety variation submissions by maintaining quality-compliant regulatory records and lifecycle activities in collaboration with affiliates and global teams.
Ensure timely and accurate submission of regulatory data to health authorities and external databases, including EMA XEVMPD.
Coordinate CSCC activities with affiliates, TPMs, and internal stakeholders to obtain Certificates, Module 1 documents, and support legalization requirements.
Maintain tracking records, monitor deliverables, and ensure timely closure of regulatory requests and activities.
Generate and maintain monthly KPIs and compliance metrics to support operational performance and management reporting.
Contribute to continuous improvement initiatives that enhance regulatory efficiency, data integrity, and compliance.
Years of Experience - 2 - 5years
Education - Science Background
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 193 comparable Associate Regulatory Affairs roles across 68 biopharma companies.
Salary context
44 of 193 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 193 comparable roles
+ 25 more countries
Seniority mix
193 of 193 peers have a known seniority level
Therapeutic area mix
10 of 193 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.