About this role
Job Title:
Executive – Regulatory Affairs
Business Unit:
R&D1 Regulatory Affairs
Job Grade
G12A
Location:
Vadodara
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 Summary
Evaluation of regulatory documents, compilation of dossier and submissions to CDSCO-HQ for regulatory approval of drug substance and drug products.
Area of responsibility:
- Evaluation of regulatory strategies for products to be registered in India
- Review of CMC & other documents, coordination with cross functional teams for necessary corrections, preparation of cover letter of application & other regulatory documents, compilation of regulatory dossier and submission on the portal of regulatory authority for obtaining,
CT, BE and domestic manufacturing and marketing permission
- Import & marketing approval in India
- Compilation of IPC testing dossier and coordination for sample readiness and submission to laboratory
- Post approval changes
- Phase IV CT applications
- Additional site notification/approval
- Condition compliance
- Checking artworks of product label and coordinate for necessary corrections
Preparation of prescribing information
Travel Estimate
NA
Job Requirements
Educational Qualification
M.Pharm
Experience
Minimum 2-5 years of relevant experience
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).