Regulatory Affairs Manager
About this opportunity
Ensure of regulatory compliance and achieving registration licenses on time from local authority, in line with company’s objectives.Location: Ha NoiNovartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.
Key ResponsibilitiesEnsure of assigned registration submission and approval on time (new registration, renewal registration, variations including new site), in line with local commercial strategies. Ensure regulatory compliance for a sustainable life-cycle management: safety label change, labeling, CMC, PSUR and other MA lifecycle support are performed in accordance with local regulations and relevant Novartis SOPsCoordinate with QA/Supply chain departments to support for product’s availability on market.Collaborate with commercial team for launching preparation, tender management and promotional material management.Ensure of regulatory database updated (DRAGON, REDI, RA Shared documents ...)Develop and maintain effective working relationships with Drug Administration of Vietnam and key Stakeholders to support current and future business activities (which are under responsibility of Regulatory Affairs).Proactively involve on shaping regulation as assignment by time.Ensure compliance to current local regulations: Awareness of current and new local regulations. Interpretation and communication of any changes that may impact Novartis in a timely manner to all relevant Stakeholders as per assignment to ensure timely implementation of new regulations and reflect on business strategy.Ensure adherence to Global and local processes & Process improvements: Compliance with Global processes and proactively identify areas of improvement with regards to local compliance. Perform other tasks relating to Regulatory activities as assigned.Minimum RequirementsUniversity graduate, preferably with a degree in Pharmacy or MedicineFluent in English and Vietnamese, enabling effective local and global collaboration5+ years of experience in Drug Regulatory Affairs or Drug Registration ManagementStrong critical and strategic thinking, with proven communication, influencing, and negotiation capabilitiesDemonstrated independent and innovative mindset, solid understanding of product‑relevant bioscience, and ability to build trust‑based relationships with key regulatory authorities
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 145 comparable Manager Regulatory Affairs roles across 41 biopharma companies.
Salary context
37 of 145 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 145 comparable roles
+ 17 more countries
Seniority mix
145 of 145 peers have a known seniority level
Therapeutic area mix
22 of 145 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.
Open in 2 locations
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.