Senior Manager Regulatory Affairs
1 week ago
Senior Regulatory Affairs Manager – UK&I
Six-figure package
Hybrid working – Home Counties 2-3 days/week
One of the world’s fastest growing consumer healthcare companies has an opportunity 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 include:
- Development of regulatory strategies, preparation of regulatory applications and support maintenance activities.
- Maintaining and seeking 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.
To apply or receive further information, email your CV to janine@tarshpartnership.co.uk
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