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.
Azurity Pharmaceuticals is proud to be an inclusive workplace and an Equal Opportunity Employer.
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 working on the Global Regulatory Affairs team you will be empowered to develop and lead global strategies to maximize global regulatory success towards achievement of program objectives for complex and multiple projects.
Principle Responsibilities
Oversees regional regulatory leads and staff responsible for ensuring global/regional regulatory strategies are written, reviewed, and executed according to plan, and provides strategic and tactical advice to allow the timely and efficient conduct of all regulatory projects.
Is a leader, contributing to cross-functional initiatives and influencing as applicable and demonstrating leadership behaviors.
Directs and oversees multiple projects (inclusive of highly complex ones) and generally has global/regional oversight for assigned products, ensuring regulatory compliance by staff and/or vendor.
Oversees and is accountable for working with other RA functions and/or vendor to ensure that regulatory submissions and approvals are achieved on schedule within area of responsibility, and understands importance of regulatory documents for value and access discussions and partners with access functions to support access applications.
Provides leadership and development for direct reports, including those that serve as regional regulatory leads responsible for designing and executing regional regulatory strategies.
Ensures 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.
Demonstrates ability to anticipate risks and is responsible for developing solutions to identified risks and discussing them with team and management.
Accountable for all global submissions and approvals of project(s) and/or oversees direct reports responsible.
Leads and manages meetings with regulatory authorities and agency meetings, or delegates and oversees direct reports and/or vendor.
Monitors and anticipates trends that impact both the regulatory and access environments to strengthen product development plan(s) 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 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.
CRO management experience preferred.
Prior managerial experience, with direct supervision of mid-to-senior-level regulatory professionals, is highly desirable.
Strong, inspiring leader who can create a vision for the group, mentor and develop staff skills, and collaborate across global teams.
Strategic thinker, planner, and implementer with excellent organizational skills.
Excellent oral and written communication skills, able to present data/issues to both technical and non-technical audiences, and able to write and edit regulatory documents.
Proven ability to plan and execute regulatory projects, delivering results within business-defined timeframes.
Proven ability to work on complex problems requiring evaluation of intangible variables.
Independent thinker with 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.
Fluent in English (written and oral).
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