Regulatory Compliance Manager
7 days ago
**Senior Regulatory Affairs Manager - UK&I**
A six-figure package is on offer for an experienced Senior Regulatory Affairs specialist to manage and support a portfolio of consumer healthcare brands.
This role is newly created, providing the opportunity for the successful candidate to shape and make it their own.
**Key Responsibilities:**
- Develop regulatory strategies, prepare regulatory applications, and support maintenance activities.
- Maintain and seek new marketing authorisations through 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 strategies for existing marketing authorisations, such as safety changes, product information updates, re-classifications, renewals, etc.
- Support the monitoring of local regulatory intelligence for the consumer healthcare team.
- Provide expert knowledge of the local regulatory authority (MHRA, HPRA, etc.).
- Collaborate strongly with local Commercial and R&D teams.
- 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/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.
**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.
- A robust understanding of the regulatory environment, interaction with regulatory authorities, commercial/strategic awareness, implementing regulatory strategy, managing and maintaining marketing authorisations.
- Experience and knowledge of local UK regulatory affairs requirements for consumer healthcare products.
- A pharmaceutical or scientific university degree would be an advantage.
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