What are the responsibilities and job description for the Executive Director, Regulatory Affairs position at Confidential?
Executive Director, Regulatory Affairs
About the Company
Fast-growing biopharmaceutical company
Industry
Biotechnology
Type
Public Company
Founded
2008
Employees
201-500
Categories
- Biotechnology
- Health Care
- Pharmaceutical
- Therapeutics
- Pharmaceuticals
- Medical Conditions
- Medical Care
- Academic Research
- Advocacy
- Business Partnerships
- Investing
- Medicine
- Manufacturing
- Chemical Products
- Healthcare
Specialties
About the Role
The Company is seeking an Executive Director for Regulatory Affairs to lead the strategic functions that support the development and commercialization of small molecule therapeutics for rare endocrine disorders and endocrine-related tumors. The successful candidate will be responsible for creating and implementing regulatory strategies for multiple products and indications, leading product teams, and managing global regulatory interactions to achieve the company's objectives. This role requires a minimum of a BS in biological sciences or a related discipline, with at least 15 years of regulatory affairs experience in a biopharmaceutical company, and a proven track record of significant regulatory accomplishments. The Executive Director will also be tasked with defining and implementing strategies to ensure compliance with regulatory guidelines, developing and managing regulatory program timelines, and overseeing the budget and headcount for the regulatory affairs function.
Applicants for the Executive Director position must have expert knowledge of US and EU regulatory requirements, with a preference for those holding an RAC certification. The role demands exceptional writing, interpersonal, and negotiation skills, as well as the ability to manage and mentor a high-performing team. Experience in drug development functions and managing third-party service providers is also preferred. The ideal candidate will have a strong background in GxPs, be well-versed in emerging regulatory technologies, and demonstrate leadership and management skills. The position is pivotal in the company's mission to transform the lives of patients, and the Executive Director will be expected to set high standards, manage risks, and stay current on industry trends to ensure the success of the regulatory affairs department.
Hiring Manager Title
Vice President of Regulatory Affairs
Travel Percent
Functions
