Senior Director - Regulatory Affairs - EU Policy & Intelligence

NonStop are searching for a Senior Director/Director of EU Regulatory Policy & Intelligence to take on a key, senior leadership role.

Stepping into a key leadership role, this position will involve active liaison with a range of EMA individuals. You will need to be an excellent communicator, as you speak to key figures within the EMA, and bring them together with our clients' stakeholders, head of functions etc.

You will identify EU regulatory policy issues/trends/changes occurring in the regulated environment that have the potential to impact products and facilitate/support the adaptation of product strategies accordingly in order to enhance asset probability of success.

The Senior Director/Director of EU Regulatory Policy will actively engage externally to shape the EU policy environment. You will be responsible for partnering with key internal functions (i.e. Development, Government Affairs, Commercial etc) and/or relevant subject matter experts to set policy agenda and engage in direct EU regulatory advocacy activities.

Benefits:

• Work for leading pharma company with rare diseases
• Drive innovative new drug launches
• Play key role in patient welfare
• Various internal growth opportunities as company expands
• Generous compensation and benefits package
• Take key leadership role in growing team
• Opportunity to travel to global office locations

Requirements:

• Extensive and relevant Regulatory / pharmaceutical experience
• Higher education (Master/PhD) preferred.
• Deep knowledge and experience with regulatory affairs and regulations in the EU.
• Successful NDA or BLA filing and approval experience; orphan/rare disease preferred.
• Demonstrable history of successfully serving in a leadership role either in, or working as a partner with, the EMA.
• Recognized expert in regulations, guidelines and precedents related to pharmaceutical development for small molecules or biologics.
• Skilled communicator and facilitator with the demonstrated ability to represent as the Company's lead liaison in opening doors for communications; a bridge-builder.
• Deep understanding of the political environment and culture within the EMA/MHRA and the ability to identify key players to be engaged.
• Significant experience interacting with senior EMA/MHRA members at Divisional and policy levels; high level of credibility and respect within the EMA/MHRA.

For a confidential discussion about this, please contact Edward Little on 0207 940 2749 (EXT: 7168) or send your updated CV in a word document to E.Little@nonstop-recruitment.com

NonStop is one of the largest and fastest growing specialised life sciences recruitment companies in Europe. We are proud members of the APSCo life sciences group who ensure we meet the highest quality standards within the recruitment industry. Our offices are located in the UK, Switzerland and the Czech Republic and we hold labour leasing licences across Europe. Please visit our website for a full list of the niche markets we cover.