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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.
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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
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