Head of Regulatory Affairs for Consumer healthcare
Our Client is a global life sciences company with a 50-year heritage in consumer healthcare, and an industry-leading portfolio of products including those in digestive health, pain care, allergy and vitamins and mineral supplements. They are a top 10 player in OTC in the UK and Ireland.
They are now seeking a Head of Regulatory Affairs for Consumer healthcare in the UK and Ireland. The role will be based in Surrey.
The successful candidate will take on rsponsibility for management and continuing professional development of the regulatory affairs team. They will be given responsibility for the regulatory affairs budget, and be charged with maintaining optimal resource capacity within this budget.
Key responsibilities will include, but are not limited to:
•Leading the management of the local maintenance activities and ensure compliance of the marketed product portfolio
•Actively following the development and emergence of new regulatory requirements and regulatory intelligence
•Ensuring that Marketing Authorizations are updated in line with Company Core Safety Information according to Corporate requirements
•Ensuring product packaging and associated information are updated, timely implemented and maintained in accordance with the current product licenses.
•Ensuring local implementation of GRA mandatory SOPs and training
•Leading development of the Local Regulatory strategies for geographical extensions
•Leading development of local strategies and preparation of OTC switches
•Leading active participation in local trade associations
Required education & experience:
•Minimum MS although Pharm D, MD, PhD or equivalent is preferred
•Minimum 5 years in Regulatory Affairs, including leadership roles
•Ability to lead teams and implement operational regulatory excellence
•Excellent understanding of the consumer healthcare and pharmaceutical industry
•Expert knowledge of European and local UK and Irish consumer healthcare regulations and requirements
•Personal experience with interactions with MHRA and/or HPRA
Role: Permanent, immediate start is available for the right candidate
Salary: Circa £100K depending on experience
Location: South East of England