Executive - Regulatory Affairs

SUN PHARMA; Panoli; Sur place; INR 800 000 - 1 100 000; Plein temps

Résumé du poste

Sun Pharma in Panoli, Gujarat, invites an Executive – Regulatory Affairs to lead GMP documentation and regulatory submissions. You will coordinate cross-functional QMS activities and ensure timely approvals for SOPs and STPs.

The role requires 4–6 years in regulatory affairs with M.Pharm/M.Sc. responsibilities include DMF/USDMF/CEP submissions and data compilation for multiple markets including ROW.

Qualifications

• M.Pharm or M.Sc in a related field.
• 4–6 years of regulatory affairs experience.
• Experience with DMF/USDMF/CEP submissions.

Responsabilités

• Review and maintain GMP documents.
• Coordinate QMS activities like Change Control.
• Approve SOPs, STPs, etc.
• Review and compile data for USDMF/CEP/DMF submissions for New DMF and amendments.
• Coordinate data for submissions to Japan, China, TGA, Canada, etc.
• Organize plant regulatory team for planning and execution.

Connaissances

GMP compliance

QMS coordination

Regulatory submissions

Document review

Formation

M.Pharm/M.Sc

Description du poste

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. 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).

Requirements: