Job Description
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