Senior Director, Regulatory Affairs, EMEA

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The Senior Director Regulatory Affairs EMEAis responsible forproviding 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 companys portfolio while ensuring compliance with applicable regulatory requirements.

The Senior Director serves as a key member of cross-functional development and commercialization teams providing regulatoryexpertiseand 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 proactivelyidentifyregulatory risks and opportunities drive successful health authority interactions and ensure the delivery of high-quality regulatory submissions that support companyobjectivesand patient -on can-do attitude isa must.

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

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. Identifyregulatory risks and opportunities and develop proactive mitigation strategies to support businessobjectives.
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 CommercialMarket Accessand other functions to drive successful outcomes.
10. Lead mentor and develop regulatory staff while promoting a culture of collaboration accountability and continuous improvement.

1. Bachelors degree in Life Sciences Pharmacy Medicine or a related scientific disciplinerequired.
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 experiencedeveloping 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 soundtimelydecisions.
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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