Executive - Regulatory Affairs

Sun Pharmaceutical Industries, Inc.; Indiana (PA); On-site; USD 8,300 - 15,000; Full time

Job summary

Sun Pharmaceutical Industries Ltd in Panoli seeks an Executive – Regulatory Affairs to manage GMP documentation, coordinate regulatory submissions, and ensure compliance across global markets.

The role requires 4–6 years of regulatory experience and a relevant postgraduate degree (M.Pharm/M.Sc). You will review documentation, support DMF submissions, and collaborate with RA teams to maintain timelines and quality.

Qualifications

• Minimum M.Pharm or M.Sc in a related field.
• 4–6 years of relevant regulatory affairs experience.
• Experience with GMP documentation and audits.
• Knowledge of DMF/USDMF submissions and global regulatory requirements.

Responsibilities

• Review and maintain GMP documents.
• Coordinate QMS activities (Change Control etc.).
• Approve documents like SOPs, STPs, etc.
• Review, follow up and compile data for USDMF/CEP/DMF submissions (New DMF) and amendments; Mumbai.
• Review, follow up and compile data for DMF amendments; Gurgaon.
• Compile data for submissions in Japan, China, TGA, Canada; coordinate ROW data; Mumbai.
• Coordinate and organize plant regulatory team for planning and execution.

Skills

Regulatory affairs

GMP compliance

Documentation management

Cross-functional coordination

Education

M.Pharm/M.Sc

Job description

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Company: Sun Pharmaceutical Industries Ltd

Job Title

Executive – Regulatory Affairs

Business Unit

R&D1 Regulatory Affairs

Job Grade

G12A

Location

Panoli

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

• To review and maintain GMP documents.
• To co‑ordinate QMS related activities like Change Control etc.
• Approval of documents like SOP’s, STP’s etc.
• To Review, follow up and compilation of data for submission of USDMF, CEP, DCP, CP, MRP for New DMF submission and DMF‑Amendment / Update based on the Planning to Corporate RA, Mumbai.
• To Review, follow up and compilation of data for submission of USDMF, DMF‑Amendment / Update based on the Planning to Corporate RA, Gurgaon.
• To Review, follow up and compilation of data for submission of Japan, China, TGA, Canadian... for New DMF submission and DMF‑Amendment / Update based on the Planning to Corporate RA, Mumbai. Compilation of raw data for Registration /re‑registration and queries received from authorities for ROW market, such as China, Korea, Taiwan, Indonesia, South Africa...etc.
• To co‑ordinate and organization of plant regulatory team for planning and execution of work based on the time line

NA

Job Requirements

Educational Qualification

M.Pharm/M.Sc

Experience

4-6 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).