Regulatory Policy Lead - Emerging Markets

A large global biotechnology company working within the fields of neurodegenerative diseases, haemophilia and autoimmune disorders, is recruiting for a Regulatory Policy Lead job at their Berkshire office.

The Global Emerging Markets (GEMS) and Asia Regulatory Policy leader will lead and develop effective approaches to GEMS and Asia regulatory policy activities, including review and setting policy agenda and priorities, coordination of the generation of positions, influencing strategy and plans, their implementation and tracking and internal communications.

The role will need to develop effective strategies to represent the company in interactions with Trade Associations and GEMS and Asia Health Authorities on advocacy issues. Foster relationships with key decision makers and leverage insider status to gain insight and intelligence.

This position will facilitate connection of internal subject matter experts on key regulatory policy issues; both reactive and proactive issues and will drive the assessment of GEMS and Asia regulatory policy issues. Align with global policy priorities and issues and partner with internal stakeholders, especially Government Affairs, Legal, Global, Regional and GEMS Regulatory Leads.

Job Responsibilities:

• Leads development of GEMS and Asia regulatory policy priorities, generates policy positions, develops action plans, tracks each and provides internal communications. Also, leads assigned global regulatory policy priorities.
• Maintains expertise of broad regulatory knowledge and policies. Focused on GEMS and Asia expertise while aligning across global regulatory knowledge and policy issues.
• In partnership with regional and local regulatory affairs team members, support the company's interactions with GEMS and Asia on advocacy issues, fostering relationships with key policy decision makers and leverage insider status to gain insight and intelligence.
• Leads and develops effective approaches to regulatory intelligence to increase awareness and utilization across the organization to support the development of effective strategies and decision making.
• Develop and maintain GEMS and Asia regulatory landscape analysis. Actively informs regulatory team on key issues, emerging regulatory and legislative changes, GEMS and Asia personnel changes and procedures that may impact the company's strategy and products.
• Represents the company on key Trade Association's committees, working groups, etc. Staff Senior internal TA representatives.
• Participate in R&D and Regulatory processes and initiatives, e.g. RCLT, PON, SOP training.

Skills and Requirements:

• 5-8 years of experience working in Regulatory or Regulatory Policy either within a Regulatory Agency and/or in the Biopharmaceutical Industry.
• Excellent working knowledge of specific countries within GEMS and Asia regional law, its interpretation and regulatory framework and how it applies to / or may impact Biopharm product development.
• A degree in law, pharmacy, medicine, or science such as a BS, MS, PhD, PharmD, or MD.
• Full-Time Regular
• Mid-Senior Level

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 Alex Czuprynski on +44 203 8692 328 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.

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