Executive - Regulatory Affairs

Job Title

Executive Regulatory Affairs (US Group)

Business Unit

R&D1 Regulatory Affairs

Job Grade

G12A

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 Summary

• Strong knowledge of USFDA, ICH guidelines, regional regulations (US, EU, India), and submission formats.
• Prepare, compile, and submit regulatory dossiers (e.g., CTD/eCTD) for new drug applications (NDAs), ANDAs, MAAs, and post-approval changes
• Support regulatory strategy development for new products and markets
• Coordinate with cross-functional teams (CDMO, R&D, Manufacturing) to gather required documentation and data.
• Respond to queries and deficiency letters from regulatory authorities
• Maintain regulatory databases and track submission timelines and approvals
  
  

NA

Job Requirements

Educational Qualification

Graduate : M.Pharm

Experience

Tenure : 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).