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. Our 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 we do. We seek highly motivated individuals with the dedication, integrity, and creative spirit needed to thrive in our organization.
By joining us as the Global Head of Regulatory Affairs, you will have significant responsibility and autonomy for your work and contributions.
As the Global Head of Regulatory Affairs on the Global Regulatory Affairs team, you will be empowered to develop and lead global strategies to maximize regulatory success toward the achievement of program objectives for complex and multiple projects.
Responsibilities
* Oversee regional regulatory leads and staff responsible for ensuring global/regional regulatory strategies are written, reviewed, and executed according to plan. Provide strategic and tactical advice and guidance to allow the timely and efficient conduct of all regulatory projects. Ensure compliance with global regulatory requirements.
* Lead cross‑functional initiatives and influence as applicable, demonstrating leadership behaviors.
* Direct and oversee multiple projects (inclusive of highly complex ones), generally with global/regional oversight for assigned products. Ensure regulatory compliance (e.g., on registration database) by staff and/or vendor.
* Work with other RA functions and/or vendor to ensure that regulatory submissions and approvals are achieved on schedule within the area of responsibility. Understand the importance of regulatory documents for value and access discussions and partner with access functions to support access applications.
* Provide leadership and development for direct reports, including regional regulatory leads responsible for the design and execution of regional regulatory strategies.
* Ensure project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner.
* Anticipate risks and develop solutions to identified risks, discussing them with the team and management; understand probabilities of technical success for the solutions.
* Be accountable for all global submissions and approvals of projects and/or oversee direct reports responsible.
* Lead and manage meetings and interactions with regulatory authorities and agency meetings; or delegate and oversee direct reports and/or vendor; negotiate on behalf of the RA team, as necessary.
* Ensure global regulatory submissions are provided in compliance with local regulations and maintain compliance for products.
* Oversee vendor responsibility for regulatory activities and submissions related to projects within scope.
* Monitor and anticipate trends that impact both the regulatory and access environments to strengthen product development plans and adopt regulatory strategies in a timely manner.
Qualifications and Education Requirements
* MD, PhD or PharmD in a scientific discipline preferred, along with 15+ years of experience in Regulatory Affairs.
* Proven success in regulatory submissions.
* FDA, EU, Canada, ROW, and post‑marketing experience is a plus with sound knowledge of such principles as GxP, FDA, and EU guidelines.
* Previous experience in attending and leading a team to prepare for major health authority interactions (e.g., FDA pre‑NDA/BLA, EOP2 meetings, advisory committee meetings and/or EU oral explanations/scientific advice).
* Experience with investigational drugs, including late‑stage development, and marketed products.
* Prior managerial experience, with direct supervision of mid‑ to senior‑level regulatory professionals, is highly desirable.
* Strong leadership skills: create a vision for the group, inspire and motivate, take a stand on important issues in a productive, respectful way, and mentor staff.
* Proficiency in regulatory strategy, risk mitigation, and creative solutions.
* Strategic thinker, planner, and implementer with excellent organizational skills.
* Excellent oral and written communication skills and ability to present data/issues to technical and non‑technical audiences, and to write and edit regulatory documents.
* Ability to plan and execute regulatory projects and a proven record of delivering results within business‑defined timeframes.
* Proven ability to work on complex problems requiring evaluation of intangible variables.
* Demonstrated potential for a high level of collaboration with others and within global teams.
* Independent thought, negotiation skills, integrity, and adaptability.
* Ability to work independently and in a virtual setting.
* MS Office skills with excellent use of Excel, PowerPoint, and MS Project required.
* Recent experience with a smaller entrepreneurial environment is a definite asset.
* Fluent in English (written and oral).
For government reporting purposes, we ask candidates to respond to the below self‑identification survey. Completion of the form is entirely voluntary; whatever your decision, it will not be considered in the hiring process or thereafter.
As set forth in Azurity Pharmaceuticals – Switzerland’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law.
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