The Role
Lead CMC regulatory activities including preparing and submitting CMC modules 2 and 3, managing product registrations and post-approval submissions, developing and executing local/regional regulatory strategies, supporting product lifecycle management, ensuring compliance with local requirements, interacting with health authorities, compiling Product Quality Reviews, and reviewing formulation, ingredient lists, claims, and labeling per SOP.
Summary Generated by Built In
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
- Review 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
- Four to six years of relevant work experience
- RAPS certification is desirable
Skills Required
- Bachelor's or Master's degree in Life Science or Pharmacy
- Four to six years of relevant regulatory affairs/CMC experience
- Experience preparing and writing CMC Modules 2 and 3
- Experience managing preparation and submission of new product registrations and post-approval submissions
- Exposure to EU and CIS region regulatory filings
- Herbal product development background
- Experience writing Product Quality Reviews (PQR)
- Experience in product lifecycle management and execution of regulatory strategies
- Experience reviewing formulation, generating ingredient lists, claims, and labeling per SOP
- RAPS certification
ClinChoice Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about ClinChoice and has not been reviewed or approved by ClinChoice.
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Flexible Benefits — Flexible arrangements, including telecommuting and flextime with no core hours in some regions, are highlighted for many roles. Feedback suggests flexibility is commonly available but depends on role and location.
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Leave & Time Off Breadth — Vacation, personal, and sick days are part of the core package, with some markets granting paid leave from the date of hire. Feedback suggests time off is standard-to-decent across locations, though specifics vary.
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Healthcare Strength — Health coverage is positioned as a core benefit, with some accounts describing overall benefits as full or good. In the U.S., healthcare sits within a conventional CRO package alongside medical, dental, and vision.
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The Company
What We Do
ClinChoice is a global full-service Contract Research Organization (CRO) specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies, aiming to accelerate the development and commercialization of innovative drugs and devices.
