Position Summary:

ultrafocused – Work together to fearlessly uncover new possibilities

The Senior Director, Regulatory Affairs – EMEA is responsible for providing strategic regulatory leadership for assigned development and marketed products across the EMEA region. This role develops and executes regional regulatory strategies that support the successful development, registration, and lifecycle management of the company's portfolio while ensuring compliance with applicable regulatory requirements.

The Senior Director serves as a key member of cross-functional development and commercialization teams, providing regulatory expertise and strategic guidance throughout all stages of product development and lifecycle management. The role requires extensive knowledge of European and international regulatory frameworks, strong leadership capabilities, and a demonstrated ability to influence decision-making across a complex matrix organization.

The successful candidate will proactively identify regulatory risks and opportunities, drive successful health authority interactions, and ensure the delivery of high-quality regulatory submissions that support company objectives and patient needs. A collaborative, hands-on, can-do attitude is a must.

Work Model:

Flex: This role will typically require onsite work 2-3 days each week, or more depending on business needs. In many locations, the business will set certain days each week that Flex employees are required to be onsite.

Responsibilities:

1. Develop and execute EMEA regulatory strategies for assigned development and marketed products.
2. Provide strategic regulatory leadership and guidance to cross-functional project teams throughout product development and lifecycle management.
3. Lead and manage interactions with regulatory agencies, including preparation, execution, and follow-up of health authority meetings.
4. Oversee the planning, preparation, review, and submission of high-quality regulatory applications and responses.
5. Identify regulatory risks and opportunities and develop proactive mitigation strategies to support business objectives.
6. Ensure regulatory activities are aligned with global development plans, regional requirements, and corporate priorities.
7. Serve as the EMEA regulatory representative on project teams, governance forums, and key business initiatives.
8. Monitor and interpret emerging regulatory requirements, trends, and guidance, and advise stakeholders on potential impact.
9. Build strong partnerships across Clinical Development, Medical Affairs, Safety, Commercial, Market Access and other functions to drive successful outcomes.
10. Lead, mentor, and develop regulatory staff while promoting a culture of collaboration, accountability, and continuous improvement.

Requirements:

1. Bachelor's degree in Life Sciences, Pharmacy, Medicine, or a related scientific discipline required.
2. Advanced degree (PhD, PharmD, MD, MSc, or equivalent) preferred.
3. Minimum of 12 years of Regulatory Affairs experience within the biotechnology and/or pharmaceutical industry.
4. Significant experience developing and executing regulatory strategies for products across various stages of development and commercialization.
5. Demonstrated experience leading major regulatory submissions and health authority interactions in Europe.
6. Strong understanding of European regulatory procedures and requirements.
7. Experience in rare diseases, biologics, advanced therapies, or specialty medicines preferred.
8. Proven ability to lead through influence, build strong cross-functional partnerships, and align diverse stakeholders around common goals.
9. Strong analytical skills with the ability to assess complex regulatory issues, manage risk, and make sound, timely decisions.
10. Excellent verbal, written, presentation, and negotiation skills, with the ability to communicate effectively at all organizational levels and with regulatory authorities.
11. Ability to coach, develop, and inspire individuals and teams while fostering a culture of accountability, inclusion, and continuous improvement.
12. Demonstrated ability to manage multiple priorities, deliver high-quality results, and successfully navigate a fast-paced and evolving environment.

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