Executive - Regulatory Affairs

Job Title

Executive Regulatory Affairs

R&D1 Regulatory Affairs

G12A

Baroda

Regulatory submission of new products, renewals, variations, response to queries and Life cycle management for MENA markets through preparation of quality dossiers enabling timely approvals.

• New submissions/Renewals:
  • Review & prepare CMC (Chemistry, Manufacturing and Controls) dossiers for fresh submissions.
  • Review documents (Development report, scale up report, specification, stability protocol), artworks etc. before initiation of Exhibit batches for adequacy.
• Approval:
  • Review & prepare response to deficiency enabling approval of products filed to regulatory agency.
• Lifecycle management for drug formulations:
  • Prepare and review variations as per the country specific requirements to support approval of changes such as API vendor changes/changes in ROS/test parameters; DF site changes; harmonization of products etc.
• Regulatory compliance:
  • Prepare, Review and circulate approval package with product history sheet to stakeholders upon receipt of approval and update the same based on queries and variations.
  • Ensure reposition of comprehensive product information into central repository.
  • Review regulatory filing impact of variations, change controls, etc.

South Africa

NA

Graduate : M.Sc /M.Pharm

Tenure : 1-4 years

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. Lets 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).

We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.