Executive - Regulatory Affairs

SUN PHARMA; Ankleshwar; On-site; INR 800,000 - 1,200,000; Full time

Job summary

Sun Pharma is seeking an Executive – Regulatory Affairs to review GMP documents, coordinate QMS activities, and approve SOPs and STPs. The role involves compiling data for DMF submissions to US, DMF amendments, and coordinating regulatory planning with Mumbai, Gurgaon, and ROW markets.

Educational background required is M.Pharm or M.Sc with 4–6 years of relevant regulatory experience. The position is based in Panoli with opportunities to collaborate across global regulatory teams.

Qualifications

• Educational background in M.Pharm or M.Sc with 4–6 years of regulatory affairs experience.
• Experience in GMP document review and QMS related activities.
• Experience with DMF/USDMF submissions is desirable but not mandatory.

Responsibilities

• Review and maintain GMP documents.
• Coordinate QMS activities like Change Control.
• Approve SOPs, STPs and related documents.
• Compile data for USDMF, CEP, DCP, CP, MRP submissions and DMF amendments for Mumbai, Gurgaon and ROW markets.
• Coordinate plant regulatory team planning and execution.

Skills

Regulatory affairs

GMP documentation

Document review

Education

M.Pharm/M.Sc

Job description

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

Travel Estimate

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).