Executive - Regulatory Affairs

5 days ago

Ankleshwar, Gujarat, India SUN PHARMA Full time

Job Title
Executive – Regulatory & Business Continuity

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 evaluate and categories QMS related activities like Change Controls w.r.t. US/EDQM/Europe/UK/Australia/Japan/Korea/CADIFA/China/South Africa guidelines
  • 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 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
  • Compilation of raw data for Registration /re-registration and queries received from authorities for ROW market, such as China, Korea, Taiwan, Indonesia, South

Travel Estimate
NA

Job Requirements
Educational Qualification
Graduate : M.Sc

Experience
Tenure : 2-5 years

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).

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