Job opportunity for M.Pharm, B.Pharm as Regulatory Affairs Senior Manager at SunGlow Life Science- Apply before 31st January 2024

  • Full Time
  • Chennai

Website SunGlow

About SunGlow

SunGlow was incorporated in January 2010 and was founded by a group of experienced industry professionals. Our corporate office is located in Chennai, India. The first facility, situated in Puducherry, a small state in the southern part of India, approximately 145 kilometers south of Chennai, manufactures products for the domestic market. The second facility is located in Chengalpattu, a town about 80 kilometers southwest of Chennai, and produces goods for the global market.

Job Post: Senior Manager – Regulatory Affairs

Job Description:

  • Responsible for the preparation and submission of dossiers for Europe, Australia, ASEAN, LATAM, and RoW countries.
  • Review all regulatory submission documents to ensure timeliness, accuracy, comprehensiveness, and compliance with regulatory standards.
  • Provide regulatory guidance to the Product Development team in terms of RLD selection, bioequivalence/bio-waiver requirements, and dossier filing strategy.
  • Coordinate with the site for preparing and checking Artwork, SPC, and PIL.
  • Coordinate and prepare site registration applications for various countries.
  • Handle queries/RFIs from Regulatory Authorities related to site and product registration.
  • Manage post-approval changes/variations.
  • Handle life-cycle management for registered products.
  • Implement regulatory affairs policies and procedures to ensure regulatory compliance is maintained or enhanced.
  • Develop regulatory strategies and implementation plans for the preparation and submission of new products.

Candidate Profile:

  • Qualification:

    B.Pharm / M.Pharm

  • Experience:

    8-12 years of experience in reputed pharma companies with strong exposure to dossier preparation and submission for Europe, Australia, LATAM, and ROW countries.

  • Candidate should possess good communication and technical writing skills.

Job Location:


Interested candidates can share their CV at:

Last Date:

31st January 2024

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