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]