Sr. Director, Regulatory Affairs – EU
Location: Maidenhead, England
Department: Regulatory EU
The Senior Director Regulatory Affairs Europe will work closely with development teams to develop strategies for regulatory submissions. The Senior Director, Regulatory Affairs, Europe will be responsible to manage, develop and register candidate drugs through regulatory product approval and commercialization. This role requires extensive experience in working and leading meetings with the EMA and an in-depth knowledge of EU regulations, knowledge of eCTD, and all regulatory requirements for EU MAA, PIP and OD submission requirements. This role is based in the European Headquarters in Maidenhead, UK.
Essential Duties and responsibilities
- Lead the generation and execution of regulatory submission plans, and direct document development, review, and finalization.
- Monitor the European regulatory affairs environment and maintain an awareness of current and future risks, issues and legislation that may impact the business, and where appropriate, influence the evolution of legislation and policy.
- Effectively communicate throughout the business to share regulatory information, intelligence and guidance and to receive and assimilate business needs, risks and issues that may have implications for regulatory affairs.
- Work with development teams to develop strategies for regulatory submissions.
- Collaborate with senior management, Product Development, Clinical Development & Operations, Manufacturing, Commercial and Quality to develop, coordinate, and implement regulatory strategies for new product development registrations, marketed products, and licensing opportunities.
- Drives implementation of department’s strategy in alignment with other department functions and company goals. Understand the regulatory environment for pharmaceutical companies, as well as pharmaceutical industry regulatory affairs best practices to satisfy regulatory requirements.
- Be a 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.
- Build effective relationships with European regulators.
- Represent the Company at European regulatory meetings and teleconferences.
- Participate as needed in European and Regulatory leadership team meetings to facilitate Regulatory's contribution to building the business.
- Other duties as required.
QUALIFICATIONS AND SKILLS
- PhD/PharmD with 8+ years of experience in European Regulatory Affairs or BSc/MS with 10+ years of experience.
- Experience in a leadership role in managing, developing and registering candidate drugs through regulatory product approval and commercialization.
- Experience in working and leading meetings with the EMA. Thorough knowledge of EU regulations, eCTD, and regulatory requirements for EU MAA, PIP and OD submission requirements.
- Ability to develop and execute successfully both short- and long-term strategic plans.
- Ability to engage and influence regulators on new approaches and implement new strategies for product regulatory filings.
- Superior scientific writing skills for developing regulatory documents
- Excellent knowledge of the regulatory requirements for medicines to treat rare diseases
- Possesses a thorough knowledge of current EU regulations and guidances of requirements for investigational products MAA submission requirements and end-to-end development experience.
- Able to generate regulatory strategies and provide leadership to multidisciplinary teams.
- Experience of successful interaction with regulatory agencies (EMA, CHMP and COMP), as demonstrated by timely submissions and approvals of pharmaceutical products.
- Possesses leadership skills and ability to interact with senior management, and to work with outside vendors and partner companies.
- Must be a demonstrated self-starter and team player with strong interpersonal skills. Must be a hands-on player.
- Develops and maintains strong collaborative internal and external working relationships.
- Excellent verbal and presentation skills
- Some US and European travel may be required