Job Title:

Manager II – India Regulatory and business Conitnuity

Business Unit:

R&D1; Regulatory Affairs

Job Grade

G11A

Location

Baroda

At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering
an environment where you grow at every step, take charge of your journey and
thrive in a supportive community.

Are You Ready to Create Your Own Sunshine? As you enter the Sun Pharma world,
you’ll find yourself becoming ‘Better every day’ through continuous progress.
Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally,
demonstrate a cooperative spirit, knowing that we ‘Thrive together’ and
support each other’s journeys.”

Key Responsibilities:

1. To evaluate regulatory strategy for products to be registered in India.
2. To co-ordinate with Cross Functional Team for getting various documents
required for filing the product in India.
3. Responsible for reviewing CMC documents to be submitted in dossier as per
regulatory guidelines.
4. To review specification for bulk drug and formulations as per regulatory




expectation.
5. Responsible for reviewing clinical trial and bioequivalence study documents
to be submitted in regulatory applications.
6. To search literature through various websites as per the application
strategy.
7. To prepare rationale on safety and efficacy of new drug/FDC by referring
published literature.
8. To prepare executive summary for SEC referral for drugs not approved in
India.
9. To get all final CMC/CT/BE final documents from cross functional team and
compilation of dossier for regulatory submission.
10. To file ND/SND/FDC application on SUGAM portal for getting domestic
manufacturing and marketing permission / clinical trial permission etc.
11. To review draft specimen or label and carton.
12. To prepare prescribing information by referring international prescribing
information.

Travel Estimate

NA

Job Requirements

Educational Qualification

Graduate : Masters (M-Pharm)

Experience

Tenure : 8-

📌 Senior Executive- India Regulatory Affairs (Vadodara)
🏢 Sun Pharmaceutical Industries
📍 Vadodara