Senior Clinical Project Manager
clinchoice
Senior Strategist - Regulatory Affairs (CMC)
clinchoice· Regulatory Affairs
About this role
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
Frequently Asked Questions
Is the salary disclosed for the Senior Strategist - Regulatory Affairs (CMC) position at clinchoice?
The salary for this Senior Strategist - Regulatory Affairs (CMC) role at clinchoice is not publicly listed. Click "Apply Now" to learn more about the compensation package on their official careers page.
Where is the Senior Strategist - Regulatory Affairs (CMC) position at clinchoice located?
This Senior Strategist - Regulatory Affairs (CMC) role at clinchoice is based in City, State/County - Country. The position is listed as on-site or hybrid. Check the full job description or apply directly to confirm the work arrangement.
Which team or department does the Senior Strategist - Regulatory Affairs (CMC) at clinchoice belong to?
This Senior Strategist - Regulatory Affairs (CMC) position is part of the Regulatory Affairs department at clinchoice. See the full job description for more information about the team structure and responsibilities.
How do I apply for the Senior Strategist - Regulatory Affairs (CMC) position at clinchoice?
Click the "Apply Now" button on this page. You will be redirected to clinchoice's official application portal hosted on greenhouse where you can submit your application directly.
When was the Senior Strategist - Regulatory Affairs (CMC) job at clinchoice posted?
This Senior Strategist - Regulatory Affairs (CMC) position at clinchoice was posted on Sep 25, 2026. Apply as soon as possible — early applications are often reviewed first.
Senior Strategist - Regulatory Affairs (CMC)
clinchoice
You'll be redirected to clinchoice's official application page on Greenhouse.