Regulatory Product Lead (UK and Ireland)

Our client, a leading biotechnology company, is looking for an experienced Product Lead (UK and Ireland) to join their team in London on a contract basis.

Job Role:
The UK-Ire Regulatory Affairs Product Lead provides regulatory strategy for Shire product portfolio in the United Kingdom, Ireland and Malta within the local business/operating company (LOC).

Role Responsibilities:

• Operational regulatory affairs activities, involving interface from LOC to European and Global RA
• Ensuring conformance to national and EU Drug Laws
• Maintaining labeling information to internal and external partners
• Communicating with national regulatory authority and regulatory institutions if required in collaboration with EU strategists
• Supporting internal Global RA, other R&D departments and providing collaborative support for commercial teams.
• Approval of specific advertising and promotional materials in accordance with UK/IE national legislation and codes of practice.
• Responsibilities include ensuring adherence to company standards and local laws.

Education and Experience

• Min 8 years within Regulatory Affairs
• Proven experience and relationship with UK and Ireland Regulatory Authorities
• Experience of working with commercial teams
• Advertising & Promotional experience - will need to have a solid understanding of this area rather than extensive experience as they will undertake internal training
• Strong team working skills and flexibility

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Peter Duvall on +44 203 0789 542 or upload your CV on our website - www.Proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.