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Research Manager – Regulatory Affairs Post Vacant @ Sun Pharma

Sun Pharma an international,specialty pharmaceutical company headquartered in India with a global manufacturing network across 25 countries. We manufacture and market a large basket of pharmaceutical formulations as branded generics & generics in India, US and across the world. Our leadership is approachable, encourages transparency & strong work ethics to ensure that people get the best opportunities to learn and grow. We encourage our employees to challenge themselves for highest level of performance through greater bandwidth of work responsibilities and growth opportunities. Apply to us if you wish to be part of Sun Pharma growth story.

Job Title : Research Manager – Regulatory Affairs

No.of.Openings : 03

Experience : 3 – 8 Years

Location : Mohali

Job Description:

  • To review & approve the master documents for manufacturing/packaging as per commercial requirements or change implementation, stability protocols, material code, additional INTM evaluation form, spec linkage form,locking & unlocking form & specification etc.
  • To support production planning & manufacturing for maximizing commits to business & to ensure timely issuance of approval information to relevant stakeholders
  • To prepare, approve & share the LP verification certificates thereby ensuring batch to batch compliance with approval information & operational documents.
  • To ensure timely availability of manufacturing & quality documents required to support regulatory submissions (variation, renewal,query/deficiency responses, annual reports, PCH submission)
  • To ensure timely availability of reviewed information through approval packages/license particular (LP) to corporate RA. To ensure implementation of changes as per approval information.
  • To assess & provide timely feedback on specifications (OOS), deviations & change controls, timely completion of trainings.

Desired Candidate Profile:

  • UG -B.Pharma
  • PG – M.Pharma
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