Develop and implement the company's regulatory strategy for all products 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
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
Qualifications:
Master's degree in a relevant field, such as pharmacy, law, or public health