Executive Director, Regulatory Affairs – EU
Location: Maidenhead, England
Department: Regulatory EU
Recognized as an influential leader, and a representative of the Company at European Regulatory meetings, the Executive Director, Regulatory Affairs, Europe will lead all regulatory activities in Europe. The Executive Director, Regulatory, Europe will have proven experience in a successful leadership role in managing, developing and registering candidate drugs through regulatory product approval and commercialization. Additionally, this role will develop and successfully execute both short- and long-term strategic plans in line with the corporate goals. This position is based in our European headquarters in Maidenhead in the UK.
Essential Duties and responsibilities
- Lead all regulatory affairs activities in
- Be the primary contact person with all European regulatory agencies, directing all submissions (including CTA, MAA, Orphan, PIP, variations, annual reports) to European regulatory agencies in a compliant and timely manner.
- Represent the Company at European regulatory meetings and teleconferences and build effective relationships with European regulators.
- Monitor and evaluate the European regulatory affairs environment. Maintain an awareness of current and future risks, issues and legislation that may impact the business, and where appropriate, provide direction, strategy and influence the evolution of legislation and policy.
- Create and implement European regulatory strategies to meet development and commercial business needs and corporate goals, at all life-cycle stages for Company products.
- Continue to build and lead an effective European regulatory affairs function with, inspection ready, relevant processes and archives to ensure full regulatory compliance.
- Manage the budget for all European regulatory affairs activities.
- Be a member of European and Regulatory leadership teams to facilitate Regulatory's contribution to building the business.
- Effectively communicate throughout the business and Executive level management to share regulatory information, intelligence and guidance and to receive and assimilate business needs, risks and issues that may have implications for regulatory affairs.
- Key contributor in building and maintaining an effective Early Access Programme.
- Contribute to building and maintaining an effective Promotional Material Review process.
QUALIFICATIONS AND SKILLS
- PhD/PharmD with 12+ years of experience in European Regulatory Affairs or BSc/MS with 15+ years of experience.
- Proven experience in a successful leadership role in managing, developing and registering candidate drugs through regulatory product approval and commercialization.
- Extensive experience in leading meetings with the EMA. In-depth knowledge of EU regulations, knowledge of eCTD, and all regulatory requirements for EU MAA, PIP and OD submission requirements.
- Demonstrated ability to develop and execute successfully both short- and long-term strategic plans.
- Ability to influence regulators on new approaches and implement new strategies for product regulatory filings in line with Corporate Goals.
- Able to negotiate on extremely critical matters, identify risk areas and issues as well as provide potential strategy and solutions for resolution to Executive management.
- Proven experience with regulatory requirements for medicines to treat rare diseases and good relationships with EMA, CHMP and COMP.
- Subject matter expert on current EU regulations and guidances of requirements for investigational products MAA submission requirements and end-to-end development experience. Must be able to generate regulatory strategies and provide leadership to multidisciplinary teams.
- A track record of successful interaction with regulatory agencies, as demonstrated by timely submissions and approvals of pharmaceutical products.
- Proactive, creative, forward-thinker with the ability to lead integrated global strategy for regulatory, approval.
- Excellent scientific writing skills for developing regulatory documents.
- Embrace and display the Company's values: Collaboration, Excellence, Courage and Compassion
- Some US and European Travel may be required.