About the 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
- 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
Aplyr's read
ClinChoice is a dynamic global CRO catering to the pharmaceutical and biotech sectors, attracting professionals skilled in regulatory affairs, biostatistics, and clinical programming.
What's promising
- •ClinChoice offers a diverse range of roles in clinical research, appealing to specialists in biostatistics and regulatory affairs.
- •The company provides opportunities for remote and hybrid work, offering flexibility to its workforce.
- •ClinChoice's global presence allows employees to engage with international projects and clients.
What to watch
- •Limited public information about ClinChoice's workplace culture and employee satisfaction.
- •The company may face competition from larger CROs with more established reputations.
- •Potential candidates might find limited career advancement information publicly available.
Why ClinChoice
- •ClinChoice focuses on comprehensive services across pharmaceuticals, biotechnology, and medical devices.
- •The company has a strong emphasis on statistical programming and regulatory affairs roles.
- •ClinChoice's recent hiring trends show a commitment to remote and hybrid work models.
Aplyr’s read is generated by AI from public sources. Was it useful?
About ClinChoice
ClinChoice is a global clinical research organization (CRO) that provides comprehensive services to the pharmaceutical, biotechnology, and medical device industries.
