We are a leading health care company with the following areas of focus: Branded Generics, Active Pharmaceutical Ingredients (APIs & Formulation), and Bio-similars. Sixty-eight percent of our business is contributed by the India operations and the rest by the export of APIs & Formulations and Branded generics.

Join Us for Regular Vacancy Updates on –

Join Our Telegram Group

Join Our Facebook Group

Position: Regulatory Affairs – Biologics

Location: Govandi, Mumbai, Maharashtra

Job Description:

1. 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
  • Work in tandem with RDPM to define the scope of work for the project, support budgeting, highlight the 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/Preclinical/clinical development
  • Conduct an evaluation of service providers and manage interactions

2. 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 (only formulations)

3. Domestic/Emerging market submissions and support

  • 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 PV guidelines and evaluates the impact of changes on USV operations (formulations only)
  • Develop content for cross-functional training to update various teams on changes in regulatory norms
  • Ensuring archival of all submissions
  • Manage budgeting and co-ordination for payments of various statutory fees (registrations & facilities) & service provider fees

  • Ensure issue of administrative documents like manufacturing license, COPP, etc. by the Indian FDA by monitoring the team member responsible
  • Review registration map of biologics
  • Oversee arrangement of registration samples

4. Plant related activities and RA support

  • 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: Appropriately Qualified

Experience: 10-15 Years

Salary: Negotiable

Contact Details:

Ms. Vaishali Pokar

hrd@usv.in

Click for More Regulatory Affair Jobs

Click for More Top Pharma Jobs


Join Us for Regular Vacancy Updates on –

Join Our Telegram Group

Join Our Facebook Group

LEAVE A REPLY

Please enter your comment!
Please enter your name here