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80 ClinChoice Jobs
Specialist-Regulatory Affairs CMC
ClinChoice
posted 21d ago
Job Role Insights
Flexible timing
Job Description
- Manage the preparation and submission of new product registrations, post approval submission and follow-up closely on queries and through approval.
- Responsible for writing CMC modules 2 & 3.
- Exposure to EU & CIS region in Regulatory filings
- Manage and coordinate product life cycle management.
- Ensure regulatory compliance with local regulatory requirements.
- Foster and maintain professional relationships with the health authorities.
- Provide regulatory support including timely registration of new product and line extensions to support new product launches, tender application, and whenever necessary.
- Maintain regulatory work processes and tracking tools that improve performance levels and transparency.
- Promote regulatory intelligence in both local and regional initiatives.
- Development of regulatory strategies, preparation of regulatory applications and support maintenance activities within relevant therapy area.
- Responsible for reviewing CMC modules.
- Execution of regulatory strategies (local and regional) in line with business plan.
- Complete regulatory activities for a defined number of products to ensure all regulatory obligations and business objectives are met.
- Ensure to adherence to timelines and quality set parameters.
- Review of Formulation, generation of ingredient list and Claims as per set standards.
- Minimum B.S. Chemistry, Pharmacy or related scientific field
- Experience in CMC regulatory affairs for pharmaceutical products.
- Experience in Module 3, Module 2.3 and relevant Module 1 e-CTD documentation
Employment Type: Full Time, Permanent
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