Home Head/VP/CEO/President/GM Head Regulatory Affairs | Bliss GVS Pharma | Mumbai

Head Regulatory Affairs | Bliss GVS Pharma | Mumbai

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Bliss GVS is a fast-growing Pharmaceutical Company with a proven track record of developing, manufacturing, and marketing high-quality pharmaceutical formulations at affordable prices for the global market. We are a public limited company listed on India’s National Stock Exchange and Bombay Stock Exchange with more than three decades of industry expertise.

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We are among the world leaders in Suppositories and Pessaries dosage forms with one of the largest portfolios in this segment. Over the last decade, we have acquired definitive know-how in other dosage forms & therapeutic segments, which is exemplified by our ever-expanding product offering across more than sixty countries.

With the significant expansion in R & D, Manufacturing & Marketing capabilities, we are poised for an accelerated rate of growth which makes for very exciting times at Bliss GVS.

Position:┬áHead – Regulatory Affairs

Location: Mumbai, Maharashtra, India

Job Description:

Roles and Responsibilities

Product Development Regulatory support:

  • Recommend strategies for new product development as per target market requirements and highlight regulatory challenges.
  • Ensure clarity on the development pathway for the molecule
  • Define the scope of work for the project, support budgeting, highlight risk to the project, and provide risk mitigation strategies
  • Periodically provide updates and present current status/plans for regulatory filings/approvals to management.
  • Discuss and review all documents related to product development including CMC/Pre-clinical/clinical development

ROW & Emerging market submissions (Primarily Africa market) :

  • Review and ensure timely submissions of (pre)-clinical trial application, registrations, re-registrations, tender documents, country-specific dossiers
  • Oversee activities of customer request management system to ensure resolution of requests such as customer queries, audits, licensing, etc.
  • Provide regulatory support for product launch management
  • Monitor changes in guidelines and evaluates the impact of changes on operations
  • Develop content for cross-functional training to update various teams on changes in regulatory norms

Regulated market submissions:

  • Review and ensure submission of completed applications for (pre)- Clinical trial/marketing authorization applications, DMF/Tech-pack, Variations/Supplements, amendments, and annual reports (post-approval changes).
  • Review documents for adequacy and correctness in all respects and ensure submission by completing the process requirements of the respective markets
  • Review and ensure timely resolution of queries raised by customer/regulator by distributing queries to relevant departments/conducting joint discussions where necessary
  • Record changes made for approval of dossier and communicate the same to plants. Archive data after receiving the Market authorization/License.

Support in plant-related activities:

  • Review and approve change controls/deviations/OOS and relevant site-related documents
  • Review quality agreement with regulatory perspective and timelines
  • Participate in and provide RA support in-plant meetings/audits/due diligence/client visits/vendor approvals etc.
  • Ensure review and proper archival of plant/R&D documents pertaining to product development/submissions etc.

Qualification: B.Pharma/M.Pharma

Experience: 14-20 Years of Relevant pharma formulation Experience

Salary: Negotiable

Contact Details:

antara.sawant@blissgvs.com, hr.careers@blissgvs.com

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