Regulatory Affairs Specialist - 1-year fixed term contract
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The RA specialist sets registration plan and perform product registration in accordance with registration and launch plan, and maintain product license with local regulation and global compliance strategy.
Major accountabilities: Major accountabilitiesReview pipeline and set the registration strategy in collaboration with global RA and related CPO functions with support from senior specialist and managerAchieve the best product registration with optimal label by conducting research on submission requirements and approval lead time in accordance with registration plan.Support launches (artwork, barcode, Drug ID mark, etc.)Perform CTA and get approval to ensure study timeline in collaboration with other CPO functions.Support IMP management through confirmation of variant number.Maintain product license by managing variations for label, quality (CMC and mfg. site) and administrative changes according to local law/regulation/guidelines, company strategy and global compliance.Secure product license by managing Reevaluation/Renewal/Reexamination /HA safety communicationEnsure post approval activities (website, artwork, etc.)Submit RMP by supporting of other function in line with global direction.Be accountable for correct and timely update of RA compliance (registration) database (DRAGON)Ensure industry compliance with NP4, KRPIA code of conductSupport cross functional activities by delivering regulatory inputUnderstand basic knowledge on the legal frameworks, internal processes, GxP’sKeep abreast of relevant laws /regulations and apply to related CPO activitiesEnsure reporting and follow up of all spontaneous adverse events (AE) and technical complaints for all Novartis products according to respective SOPFoster and maintain good relations with internal and external stakeholders.Communicate effectively with HA and other BFsUnderstand RA internal working process and handle own task wellEssential RequirementsEducation: 4-year university degree, preferably in Pharmacy, Biochemistry, Chemistry, Life Sciences, or a related fieldLanguages: Fluent in both written and spoken EnglishExperience: Pharmaceutical industry experience preferredKnowledge: Basic understanding of regulatory affairs, drug development process, and applicable pharmaceutical regulations/guidelines preferred
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 438 comparable Regulatory Affairs roles across 98 biopharma companies.
Salary context
119 of 438 peers report a salary range (USD, annualized)
Peers share this role's job function. This posting doesn't list a seniority level, so peers aren't narrowed by seniority either -- the range below may span more levels than usual.
Where these roles are based
Top locations among the 438 comparable roles
+ 46 more countries
Seniority mix
348 of 438 peers have a known seniority level
Therapeutic area mix
36 of 438 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.
Matched on job function only -- seniority, specialty, and location weren't confirmed as aligned.
Matched on job function only -- seniority, specialty, and location weren't confirmed as aligned.
Matched on job function only -- seniority, specialty, and location weren't confirmed as aligned.
Matched on job function only -- seniority, specialty, and location weren't confirmed as aligned.
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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.