“Regulatory Affairs Assistant Manager Wanted at Sudeep Pharma”

About Sudeep Pharma

Sudeep Pharma Private Limited, established in 1989, has emerged as a trailblazer in the pharmaceutical sector, particularly excelling in the production of excipients and mineral actives. Recognized for its commitment to innovation, the company has not only broadened its scope to include specialty pharmaceutical ingredients but has also ventured into the Food and Nutrition Segments. By incorporating advanced technologies, Sudeep Pharma continues to stay at the forefront of industry trends, showcasing its dedication to progress and excellence.

Assistant Manager – Regulatory Affairs

Job Description:

• Address Technical Queries: Handle all technical inquiries from customers effectively.
• Specification Management: Update and verify all specifications in coordination with the production and QC teams.
• Customer Specification Management: Ensure customer specifications are updated and validated with production and QC teams.
• Record Keeping: Maintain records of special customer requirements.
• Data Analysis: Analyze raw material and finished product testing results to facilitate decision-making by management.
• Complaint Analysis: Analyze product and unit-wise complaints for management review.
• Sample Requests Management: Manage and review sample requests from customers.
• Quality Coordination: Coordinate with customer QC teams for harmonization of test methods.
• Production Coordination: Coordinate with customer production teams for necessary modifications in product quality.
• Complaint Resolution: Address customer complaints via email communication and review CAPA effectiveness with relevant departments.
• R&D Support: Assist in coordinating R&D and QC teams for new product development.
• Vendor Qualification Assistance: Assist customers in their vendor qualification procedures.
• Additional Responsibilities: Undertake any additional tasks as required. In the absence of the assistant manager, her colleague will be responsible for completing her duties.

Additional Information:

• Experience: Minimum 6 years
• Qualification: B.Pharm, M.Pharm, M.Sc.
• Location: Nandesari, Vadodara
• Industry Type: Pharma/ Healthcare/ Clinical research
• Functional Area: Regulatory Affairs
• End Date: 30th March 2024
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