Senior Director / Regulatory Affairs Head EU
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Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company focused on innovative products that meet the needs of underserved patients. 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. We seek highly motivated individuals with dedication, integrity, and a creative spirit to thrive in our organization.
Purpose and scope
If you are looking to be part of a dynamic, global, fast-growing organization, you will have broad responsibility and autonomy as the Head of Regulatory Affairs – EU, with fast and effective cross-department communication.
Responsibilities
* Provide EU regulatory strategy and leadership for the existing and future portfolio of assets.
* Advise internal teams and management on regulations, guidance, and industry best practices.
* Perform regulatory reviews, collaborate with cross-functional leaders to facilitate discussions and evaluate regulatory risks.
* Oversee MLR (medical, legal, regulatory) review committee outcomes.
* Advise on SOPs and work instructions to ensure high-performing regulatory operations and effective review processes.
* Coach and mentor the team on evolving regulatory requirements, new regulations, guidance, and enforcement.
* Recruit, develop, and act as advisor and coach to direct reports and junior regulatory team members.
Qualifications and education
* Bachelor’s degree in Life Science or related discipline with at least 15+ years of regulatory experience.
* Thorough understanding of the EU regulatory landscape.
* Proven experience in leading dynamic teams, fostering efficiency and teamwork.
* Demonstrated track record of successful product launches.
* Excellent organizational, interpersonal, verbal, and written communication skills.
* Strong network and working rapport with regulatory authorities, agencies and third-party consultants.
* Ability to adapt to changing environments with flexibility, empathy, and urgency.
Seniority
* Executive
Employment type
* Full-time
Job function
* Legal
Industries
* Pharmaceutical Manufacturing
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