Senior Executive - India Regulatory Affairs

Job Title:

Regulatory and Business Continuity

Business Unit:

R&D1 Regulatory Affairs

Job Grade

G11B – Senior Executive

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.”

       Job Description

• Person should be well experienced in the below activities (planning, filing, managing, etc.):


• Overall managing regulatory applications to CDSCO (DCGI) related to:


• Bioavailability (BA)/Bioequivalence (BE) export applications, query response, protocol amendments, site transfer, investigator change, etc.


• Import licence applications, query response.


• CT-10/12/13 applications, query response


• Export NOC applications.


• Clinical trial applications.

Travel Estimate

NA

Job Requirements

Educational Qualification

M. Pharm

Experience

Tenure: 4 – 8 Yrs.

Your Success Matters to Us

At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let’s create a brighter future together

Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification.  It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job.  Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).