Senior Manager Regulatory Affairs

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 [email protected]