Senior Executive- India 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 collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.”

Key Responsibilities:

• To evaluate regulatory strategy for products to be registered in India.

• To co-ordinate with Cross Functional Team for getting various documents required for filing the product in India.

• Responsible for reviewing CMC documents to be submitted in dossier as per regulatory guidelines.

• To review specification for bulk drug and formulations as per regulatory expectation.

• Responsible for reviewing clinical trial and bioequivalence study documents to be submitted in regulatory applications.

• To search literature through various websites as per the application strategy.

• To prepare rationale on safety and efficacy of new drug/FDC by referring published literature.

• To prepare executive summary for SEC referral for drugs not approved in India.

• To get all final CMC/CT/BE final documents from cross functional team and compilation of dossier for regulatory submission.