Regulatory Affairs Executive – Formulation
Company: Ipca Laboratories Limited
Location: West Mumbai
Salary: ₹11.6 Lakhs per year
Experience: 4 – 8 years
Qualification: M.Sc., B.Pharm, or M.Pharm
About the Job
Join Ipca Laboratories Limited as a Regulatory Affairs Executive, specializing in formulation for the European market. This role is perfect for candidates with a strong background in pharmaceutical manufacturing and regulatory affairs.
Key Responsibilities
- Submission Activities:
- Handle submission-related activities for the European market.
- Support contract manufacturing projects by ensuring regulatory compliance.
- Liaison Work:
- Communicate with customers regarding product licenses and implement necessary changes at the manufacturing site.
- Coordinate with stakeholders to gather and review technical documents for EU submissions and customer Marketing Authorizations (MAs).
- Coordination with R&D:
- Work closely with the R&D and Analytical Development departments to finalize technical documents and specifications.
- Product Dossiers:
- Compile product dossiers required for regulatory submissions.
- Query Responses:
- Respond to regulatory agencies’ queries to facilitate product approval processes.
- Application Review:
- Review post-approval variation applications prepared by subordinates to ensure they are accurate and complete.
- Database Maintenance:
- Maintain databases to keep track of submissions, grants, and approvals.
- Site Transfer Monitoring:
- Oversee site transfer activities and ensure timely submission of documentation and approval.
- Technical Support:
- Provide technical support to marketing managers regarding regulatory affairs.
- Regulatory Updates:
- Stay updated with current regulatory guidelines and ensure all activities comply with these regulations.
Required Skills
| Skill | Description |
|---|---|
| Good Manufacturing Practice | Expertise in GMP protocols and compliance. |
| HAZOP Study | Proficiency in Hazard and Operability Study methodologies. |
| Regulatory Knowledge | Familiarity with EU regulatory frameworks and guidelines. |
Meta Description
“Join Ipca Labs as a Regulatory Affairs Executive in Mumbai with 4-8 years of experience in EU market compliance.”
