Vice President of Regulatory Affairs
Cellphire Therapeutics is a Rockville, MD-based biotechnology company focused on developing platelet-based products to save lives. Our lead product, Thrombosomes®, is a platelet-based freeze-dried hemostatic. Cellphire’s goal is to revolutionize hemostasis management through the development of the next generation of platelet-based products that will efficiently stop bleeding. We believe that our products will ensure platelet availability to all patients regardless of location or environment.
The Vice President of Regulatory Affairs, Office of Blood Products is responsible for leading the strategic and operational aspects of regulatory compliance and submissions for all blood products and related services across the company. This includes developing and managing regulatory strategies, ensuring compliance with all applicable regulations, and interacting with regulatory agencies. The ideal candidate will have a strong understanding of the regulatory landscape for blood products, as well as experience in leading and managing a team of regulatory professionals.
Essential Duties and Responsibilities:
Develop and implement the company's regulatory strategy for all blood products and related services aligned with business objectives and global regulatory requirements.
Ensure compliance with all applicable regulations, including those of the FDA, EMA, and other regulatory agencies
Manage/Oversee preparation, review, and submission of regulatory documents for all products (IND, BLA, and international regulatory submissions)
Interact with regulatory agencies on behalf of the company
Build and maintain relationships with key stakeholders in the regulatory community
Provide regulatory guidance to other departments within the company
Collaborate with Clinical Development teams to ensure regulatory compliance in clinical trial design, conduct and reporting.
Provide regulatory guidance to ensure trials are conducted in accordance with regulatory standards.
Work closely with cross-functional teams, including R&D, clinical, quality, and manufacturing, to ensure alignment on objectives to meet regulatory and post-licensure requirements.
Stay up-to-date on the latest regulatory developments
Education: Master's degree in a relevant field, such as pharmacy, law, or public health
Advanced regulatory affairs certifications required.
10+ years of experience in regulatory affairs, with at least 5 years of experience in the blood products industry
Strong understanding of the regulatory landscape for blood products
Experience in leading and managing a team of regulatory professionals
Excellent written and verbal communication skills
Ability to work independently and as part of a team
Strong analytical and problem-solving skills, with a strategic mindset
Additional Preferred Qualifications:
Experience in the Office of Blood Products at the FDA
Experience with the development and approval of new blood products
Experience with the regulation of blood banks and transfusion services
Domestic/International Travel: 15%
Physical Demands: Should be able to sit at the desk or stand at a computer for prolonged periods.
All your information will be kept confidential according to EEO guidelines.