Executive - Regulatory Affairs

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

Job summary

Sun Pharma in Panoli (Gujarat) seeks an Executive – Regulatory Affairs to maintain GMP documents, coordinate QMS activities, and support global regulatory submissions. The role involves preparing data for USDMF, CEP, DCP, CP, and DMF amendments, plus alignment with Mumbai, Gurgaon teams and ROW markets.

M.Pharm or M.Sc with 4–6 years of experience preferred; candidate will work in a collaborative regulatory team.

Qualifications

• M.Pharm or M.Sc in relevant field.
• 4–6 years of regulatory affairs experience in pharma.

Responsibilities

• Review and maintain GMP documents.
• Coordinate QMS activities like Change Control.
• Approve documents such as SOPs and STPs.
• 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.
• Review, follow up and compilation of data for submission of USDMF, DMF-Amendment / Update based on the Planning to Corporate RA, Gurgaon.
• 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.
• Coordinate and organize plant regulatory team for planning and execution of work based on the time line

Education

M.Pharm/M.Sc

Job description

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

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.

• 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!

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).