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Senior Regulatory Affairs Manager
2 months ago
About the Role
Tarsh & Partners Marketing Recruitment is seeking an experienced Senior Regulatory Affairs Manager to join our client's team in the UK. As a key member of the consumer healthcare team, you will be responsible for developing and implementing regulatory strategies to ensure compliance with local and regional regulations.
Key Responsibilities
- Develop and maintain regulatory strategies for consumer healthcare products
- Prepare and submit regulatory applications and support maintenance activities
- Maintain and seek new marketing authorisations through national and European procedures
- Develop and support regulatory strategies for local and regional markets
- Portfolio responsibility for full life cycle management, including local responsibilities for defining and implementing submission strategies for existing marketing authorisations
- Support the monitoring of local regulatory intelligence for the consumer healthcare team
- Provide expert knowledge of local regulatory authorities, including the MHRA and HPRA
- Collaborate with local commercial and R&D teams to ensure efficient compliance with external, local, regional legislation and internal compliance obligations and requirements
- Represent local Regulatory Affairs in audits and inspections
- Provide regulatory advice and perform due diligence for product acquisitions and distributor agreements with third parties
- Maintain strong awareness and knowledge of current regulatory legislation
- Ensure regulatory best practice at all times
- Monitor changes in the regulatory environment and highlight any potential impact to the company
Requirements
- A background in consumer healthcare in a local (UK) role
- Experience in planning, conducting, and managing regulatory submissions and multiple projects
- Proven project management skills
- Robust understanding of the regulatory environment, interaction with regulatory authorities, commercial/strategic awareness, and implementation of regulatory strategy
- Experience and knowledge of local UK regulatory affairs requirements for consumer healthcare products
- A pharmaceutical or scientific university degree would be an advantage
About Us
Tarsh & Partners Marketing Recruitment is a leading recruitment agency specialising in marketing and regulatory affairs roles. We work with top companies in the consumer healthcare industry to find the best talent for their teams.