Senior Strategist - Regulatory Affairs (CMC)
ClinChoice · City
Responsibilities:
- Manage the preparation and submission of new product registrations, post approval submission, and follow-up closely on queries and through approval
- Responsible for reviewing and writing CMC modules 2 and 3
- Exposure to EU and CIS region in regulatory filings
- Herbal product development background
- 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 and tender applications when necessary
- Maintain regulatory work processes and tracking tools that improve performance levels and transparency
- Exposure in writing of Product Quality Review
- Promote regulatory intelligence in both local and regional initiatives
- Develop regulatory strategies, prepare regulatory applications, and support maintenance activities within relevant therapy areas
- Execution of regulatory strategies (local and regional) that are in line with the business plan
- Complete regulatory activities for a defined number of products to ensure all regulatory obligations and business objectives are met
- Ensure adherence to timelines and quality set parameters R
- eview of formulation, generation of ingredient list, and claims per set standards
- Compilation and review of labeling components per SOP
Deliverables:
- CMC modules 2 and 3
- Management of the preparation and submission of new product registrations, post approval submissions, and follow-up on queries through approval
- Review of CMC modules
- Execution of regulatory strategies (local and regional) that are in line with the business plan
- Compilation of PQR as per SOP – Summary report of variations submitted as per the specified period.
- Review of formulation, generation of ingredient list, and claims per set standards
- Compilation and review of labeling components per SOP
Experience/Qualifications:
- Bachelor’s/Master’s degree in Life Science/Pharma
- Six to eight years of relevant work experience
- RAPS certification is desirable