Regulatory Affairs Manager
4 days ago
Job Title: Senior Manager Regulatory Affairs
Company: Tarsh & Partners Marketing Recruitment
Job Type: Full-time
Location: Home Counties (Hybrid working)
Job Description:
Regulatory Affairs Manager Job Summary:
We are seeking an experienced Regulatory Affairs Manager to join our team at Tarsh & Partners Marketing Recruitment. As a Senior Manager Regulatory Affairs, you will be responsible for managing and supporting a portfolio of consumer healthcare brands.
Key Responsibilities:
- Develop and implement regulatory strategies to ensure compliance with local and regional regulations.
- Maintain and seek new marketing authorisations through the National and European Procedures.
- 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 highlights any potential impact to the company.
Candidate 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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