Manager Regulatory Affairs - Delhi (Delhi, India, Delhi)
About this opportunity
The Position
Ensure that all regulatory updates are shared with local and global teams in timely manner. Ensure that timely and complete regulatory actions are taken regarding assigned product/therapeutic area. Ensure operational RA tasks are executed in timely manner
Tasks & Responsibilities
Registration of NCE and line extensions for therapeutic area of responsibility
Strategies compliant with regulations, Liaise with Health Authority and ensure earliest submission and registration in the country.
Follow-up regulatory approvals for the products per registration plan.
Liaise with Health Authority regularly and engage in impactful discussion with Senior Regulatory officials.
Ensure earliest submission & approvals at the right time to ensure quick implementation of proposed CMC changes as per global timelines.
Renewal on time to ensure uninterrupted availability of products in the country.
Amendments and updates are approved on time to ensure study is continued in the country and ensure timely notification of notifiable updates.
Follow-up on submitted applications at HA.
Regulatory Intelligence, ensure all regulatory updates are shared with local and global team in timely manner. Follow the RI procedure of making entry and impact assessment of each relevant update in RINTOOL to maintain RIN database.
Requirements
Education: Bachelor’s degree in pharmacy or similar medical education.
Pharma experience with regulatory focus in a multi-national for at least 8-10 years.
Proven track record of Strong Liaising experience in the health authority
Solid understanding of D&C Act and Rules.
Understanding of working practices at HA.
Experience of direct interactions with Regulatory Authorities.
Eye for details
Analytical skills
Communication skills
Negotiation skills
Position is based in Delhi
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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 192 comparable Manager Regulatory Affairs roles across 64 biopharma companies.
Salary context
52 of 192 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 192 comparable roles
+ 27 more countries
Seniority mix
192 of 192 peers have a known seniority level
Therapeutic area mix
16 of 192 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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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.