Senior Executive Director, Regulatory Affairs
Confidential, San Diego, CA, United States
Senior Executive Director, Regulatory Affairs
About the Company
Well-funded clinical-stage biotech company
Industry Biotechnology
Type Privately Held
About the Role
The Company is seeking a Senior Executive Director for Regulatory Affairs to play a pivotal role in the organization's expansion and the development of innovative products, particularly in the women's health space. The successful candidate will be a hands-on leader, comfortable in a fast-paced biotech environment, and will be responsible for providing strategic and tactical support in regulatory activities. This includes global regulatory strategy, managing health authority interactions, and ensuring that the development of clinical assets aligns with regulatory requirements. The role is highly visible and demands a professional with a creative mindset, strong experience in leading FDA meetings, and a proven track record in guiding new assets through various approval stages.
Applicants for this role at the company should have a Bachelor's degree in a scientific field, with an advanced degree preferred, and at least 10 years of regulatory experience in the pharmaceutical or biotech industry, with a focus on new clinical assets. Experience in women's health therapeutics and a background in small to mid-size biotech companies are also strongly preferred. The role requires the ability to establish and maintain excellent relationships with regulatory agency personnel, negotiate directly with authorities, and ensure compliance with regulatory requirements. The ideal candidate will be a proactive, collaborative professional who can provide regulatory expertise and manage timelines effectively, while also being prepared to take on a leadership role as the company continues to grow.
Hiring Manager Title Chief Scientific Officer
Travel Percent Less than 10%
Functions
Medical Care/Hospital Administration
About the Company
Well-funded clinical-stage biotech company
Industry Biotechnology
Type Privately Held
About the Role
The Company is seeking a Senior Executive Director for Regulatory Affairs to play a pivotal role in the organization's expansion and the development of innovative products, particularly in the women's health space. The successful candidate will be a hands-on leader, comfortable in a fast-paced biotech environment, and will be responsible for providing strategic and tactical support in regulatory activities. This includes global regulatory strategy, managing health authority interactions, and ensuring that the development of clinical assets aligns with regulatory requirements. The role is highly visible and demands a professional with a creative mindset, strong experience in leading FDA meetings, and a proven track record in guiding new assets through various approval stages.
Applicants for this role at the company should have a Bachelor's degree in a scientific field, with an advanced degree preferred, and at least 10 years of regulatory experience in the pharmaceutical or biotech industry, with a focus on new clinical assets. Experience in women's health therapeutics and a background in small to mid-size biotech companies are also strongly preferred. The role requires the ability to establish and maintain excellent relationships with regulatory agency personnel, negotiate directly with authorities, and ensure compliance with regulatory requirements. The ideal candidate will be a proactive, collaborative professional who can provide regulatory expertise and manage timelines effectively, while also being prepared to take on a leadership role as the company continues to grow.
Hiring Manager Title Chief Scientific Officer
Travel Percent Less than 10%
Functions
Medical Care/Hospital Administration