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My client is seeking a Director of Regulatory Affairs to lead regulatory strategy and the company’s interactions with the FDA and other regulatory agencies. She/he will work closely with our scientific team and external advisors to build relationships with those agencies, help guide the development team to meeting the requirements for advancing therapeutic candidates into the clinic, and will lead the preparation and submission of IND-filings, coordinate regulatory aspects of clinical trials, and serve as the primary point of contact with regulatory agencies. The position provides the opportunity to join a creative, energetic and innovative research and development team.
* Develop and execute regulatory strategies to support the advancement of products from preclinical to clinical stages, ensuring compliance with applicable regulations and guidelines.
* Lead the preparation, submission, and management of IND-filings and regulatory documentation for clinical trials, collaborating with cross-functional teams to ensure timely and high-quality submissions.
* Work closely with internal scientific teams to ensure timely and accurate reporting of scientific data necessary for regulatory filings.
* Serve as the primary point of contact for regulatory agencies, fostering strong relationships and effectively communicating with regulatory authorities to address questions, provide necessary information, and resolve issues.
* Bachelor’s or advanced degree in life sciences, pharmacy, or a related field.
* 5+ years’ experience in regulatory affairs within the biotech or pharmaceutical industry, with a focus on IND submissions and Phase I/II clinical trials.
* Demonstrated track record of successfully leading regulatory submissions, including IND applications and interactions with regulatory authorities.
* In-depth knowledge of FDA regulations, guidelines, and procedures relevant to drug development and clinical trials.
* Strong understanding of the drug development process, including preclinical, clinical, and regulatory requirements. Experience in autoimmunity and/or immuno-oncology preferred.
* Strong communication and interpersonal skills, with the ability to effectively collaborate and influence cross-functional teams and build relationships with regulatory authorities.
* Detail-oriented with excellent organizational, project management, and problem solving abilities.
* Ability to work in a fast-paced, dynamic startup environment and adapt tochanging priorities and deadlines.