Senior Director / Regulatory Affairs Head EU

Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline. The company’s patient-centric products span the cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, and have benefited millions of patients. For more information, visit www.azurity.com.

Azurity Pharmaceuticals is proud to be an inclusive workplace and an Equal Opportunity Employer. Azurity's success is attributable to our incredibly talented, dedicated team that focuses on benefiting the lives of patients by bringing the best science and commitment to quality into everything that we do. We seek highly motivated individuals with the dedication, integrity, and creative spirit needed to thrive in our organization.

Brief Team/Department Description:

If you are looking to be a part of a dynamic, global, fast-growing organization, have a positive attitude, are willing to develop yourself, and are energized by being a part of improving the health of others, we are the perfect match for you. By joining us as the Head of Regulatory Affairs – EU your position will be broad, communication between departments will be fast and effective and you will have significant responsibility and autonomy for your work and contributions.

Principle Responsibilities:

As the Head of Regulatory Affairs – EU, you will be leading, further building and developing the EU RA team, empowered to develop and lead regulatory strategies to achieve Azurity’s true north goals.

Duties & Responsibilities:

• Responsible for providing EU regulatory strategy and leadership for existing and future portfolio of assets.
• Advise internal teams and management on regulations, guidance, and industry best practices.
• Perform regulatory reviews, work with cross-functional leaders to facilitate discussions and evaluate regulatory risks.
• Oversee MLR (medical, legal, regulatory) review committee outcomes
• Advise on SOP’s and Work Instructions as applicable, to ensure high performing regulatory operations and effective review processes.
• Coach and mentor the team on changing regulatory environment for new regulations, guidance, and enforcement.
• Recruit, develop and act as an advisor and coach to direct reports and junior members of the regulatory team.

Qualifications and Education Requirements

• Bachelor’s degree in Life Science or other related disciplines with at least 15+ years of Regulatory experience.
• Thorough understanding of EU Regulatory landscape.
• Proven experience in leading dynamic teams, fostering a culture of efficiency and teamwork.
• Demonstrated track record of successful product launches.
• Excellent organizational, interpersonal, verbal, and written communication skills.
• A strong network and working rapport with regulatory authorities, agencies and third-party consultants.
• The ability to adapt to changing environment and circumstances requiring flexibility, empathy and sense of urgency.

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