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

Head Regulatory Affairs | Bliss GVS Pharma | Mumbai


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.

Join Us for Regular Vacancy Updates on –

Join Our Telegram Group

Join Our Facebook Group
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

Click for More Regulatory Jobs

Click for More Top Pharma Jobs

Join Us for Regular Vacancy Updates on –

Join Our Telegram Group

Join Our Facebook Group


Please enter your comment!
Please enter your name here

Must Read

Area Business Manager | Koye Pharmaceuticals | All Over India

Koye was launched to seek, identify and introduce to the market, essential drugs in areas of Speciality Primary Care, Respiratory, Gynaecology, IVF, Diabetology, Metabolics...