Vice President Regulatory Affairs

Vice President Regulatory Affairs About the Company Revolutionary biotechnology company

Industry
Biotechnology

Type
Privately Held








About the Role The Company is seeking a Vice President of Regulatory Affairs to play a pivotal role in ensuring the regulatory compliance and driving strategic initiatives for their innovative, life-saving blood products. The successful candidate will be responsible for crafting and executing regulatory strategies that align with business goals and global requirements, as well as overseeing the preparation and submission of regulatory documents to authorities such as the FDA and EMA. This leadership position involves engaging with regulatory agencies on behalf of the company, and collaborating with the Clinical Development team to ensure compliance in the conduct of clinical trials.

The ideal candidate for the Vice President of Regulatory Affairs role at the company will have a Master's degree in a field such as regulatory affairs, pharmacy, law, or public health, and possess advanced regulatory affairs certifications. A minimum of 10 years' experience in the industry, with at least 5 years focused on regulatory affairs for blood products, is required. The role calls for a leader with proven experience in team management, and experience in the FDA's Office of Blood Products is a plus. Responsibilities include not only ensuring compliance with regulatory bodies and leading the regulatory strategy, but also contributing to the global impact of the company's products. The candidate should be prepared to work closely with a dynamic and dedicated team, and while the position is remote, a high level of engagement and influence on the global regulatory landscape is expected.




Travel Percent
Less than 10%

Functions Medical Care/Hospital AdministrationStrategyOperations