Senior Manager, Regulatory Affairs
4 days ago
Senior Regulatory Affairs Manager - UK&I
Job Type: Full-time
Location: Hybrid working - Home Counties 2-3 days/week
About the Role:
We are seeking an experienced Senior Regulatory Affairs specialist to manage and support a portfolio of consumer healthcare brands. As a key member of our team, you will be responsible for developing and implementing regulatory strategies, preparing regulatory applications, and supporting maintenance activities.
Key Responsibilities:
- Develop and support regulatory strategies (local and regional)
- Portfolio responsibility for full life cycle management, including local responsibilities to define and implement submission strategy for existing marketing authorisation such as safety changes, product information updates, re-classifications, renewals, etc.
- Support the monitoring of local regulatory intelligence for consumer healthcare team
- Provide expert knowledge of the local regulatory authority (MHRA, HPRA, etc.)
- Strong collaboration with the local Commercial and R&D teams
- Ensure efficient compliance to 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/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 regulatory environment, interaction with the Regulatory Authorities, commercial/strategic awareness, implement regulatory strategy, managing and maintaining Marketing Authorisations
- Experience and knowledge of local UK regulatory affairs requirements for consumer healthcare products
- Pharmaceutical or scientific university degree would be an advantage
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