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Regulatory Affairs Specialist
2 months ago
ClinChoice is seeking an experienced Regulatory Affairs Manager (OTC products) for a 3-month contract to work with one of our Consumer Health partners, focusing on over-the-counter (OTC) Pharmaceuticals.
Key Responsibilities:- Manage products or specified products within a therapy area for OTC Medicines, Cosmetics, Medical Devices, and/or Food Supplements.
- Develop regulatory strategies, prepare regulatory applications, and support maintenance activities within relevant therapy areas.
- Support the team with regulatory activities for National and/or European procedures (Decentralised, Mutual Recognition) as appropriate.
- Support the team with regulatory strategies (local and regional) in line with business plans.
- Support the team to complete identified regulatory activities to ensure all regulatory obligations and business objectives are met.
- Prepare and compile regulatory submissions (Marketing Authorisations, Reclassifications, etc.), responses to Regulatory Agency questions, and other correspondence in accordance with EU regulations and guidelines.
- Sign off of packaging material, leaflets, SmPCs, and advertising material (as appropriate) to ensure regulatory compliance for submissions via the relevant internal systems.
- Inform the Regulatory Agency/Department of Health (as appropriate) of product discontinuations and licence cancellations.
- Global, Regional, and local databases are fully maintained.
- Update relevant local and global databases to track current product information.
- Provides regulatory advice and performs due diligence for product acquisitions and distributor agreements with third parties (as appropriate).
- Maintain awareness/knowledge of current regulatory legislation.
- Ensures regulatory best practice at all times.
- Monitor changes in the regulatory environment and highlight any potential impact on client products.
- May act as an ambassador for the Regulatory Affairs department to raise the profile of the team both internally and externally.
- May represent Regulatory Affairs on cross-functional product/project teams and provides regulatory advice (as appropriate).
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies.
We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.
Our Company Ethos:
Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices.
Our employees are the most valuable company asset, and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel.
The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology.
