Senior Director, Regulatory Affairs

Bachelor's degree and a minimum of 10 years of direct experience in Regulatory Affairs. Rare disease, neurology, CMC, advanced degree (MS, PharmD, PhD), and/or combination product experience a plus. Demonstrated track record of successful interactions with FDA and other Health Authorities. Expert understanding of scientific principles and regulatory requirements for global drug development. Experience preparing nonclinical and clinical sections of regulatory filings (IND/CTAs, PIPs, briefing documents, BLA/MAAs). Experience preparing for and conducting Regulatory meetings with global Health Authorities. Strong interpersonal skills and ability to collaborate effectively. Demonstrated leadership, problem-solving ability, flexibility, and teamwork. Excellent communication, writing, and presentation skills. Strong project management skills. Ability to work effectively in a fast-paced, collaborative, and dynamic environment.

Develop and execute global regulatory strategies. Serve as global regulatory lead for the MMN program. Provide expert guidance to cross-functional teams. Drive global regulatory submissions. Act as primary liaison with Health Authorities. Interpret Health Authority regulations and guidance documents. Lead planning and support for regulatory submission documents (INDs/CTAs, DSURs, PIPs, HA queries, briefing documents). Serve as primary contact and build relationships with Health Authorities. Maintain expert knowledge in US and international regulations. Assess opportunities and oversee applications for expedited pathways and orphan drug designations. Lead preparation for and conduct of Health Authority meetings. Evaluate competitive landscape, regulatory approval pathways, and labeling precedents. Identify, engage, and collaborate with external regulatory experts. Perform regulatory strategic assessments for new product candidates and indications. Support departmental initiatives including process development, regulatory intelligence, and budgeting.