Sr. Director, Regulatory Affairs

Description Sr. Director, Regulatory Affairs At Merida Biosciences, we are pioneering true precision medicines for antibody-driven diseases. We specifically target pathogenic antibodies and their cellular sources with bespoke Fc biotherapeutics engineered to selectively and completely eliminate the root causes of autoimmune and allergic diseases, and to achieve deep, durable responses while preserving essential immunity. We are looking for passionate individuals to join our mission to transform treatment paradigms across the spectrum of antibody-driven diseases. Merida Biosciences is seeking an experienced and strategic Senior Director, Regulatory Affairs to lead and execute global regulatory strategies across our development programs. This individual will serve as a key cross-functional leader and regulatory expert, partnering closely with Program Leadership & Management, Clinical Development, Clinical Pharmacology, Clinical Operations, Biostatistics, Pharmacovigilance, CMC, Nonclinical, Quality, and Executive Leadership to advance innovative therapeutics through development and key regulatory milestones. The ideal candidate brings deep regulatory expertise within biotechnology, strong leadership capabilities, and a collaborative, solutions-oriented mindset suited for a fast-paced and innovative environment. This role will have significant visibility across the organization and will play a critical role in shaping regulatory strategy and health authority interactions. Key

Responsibilities Lead the development and execution of global regulatory strategies for assigned development programs from early development through commercialization. Serve as the regulatory strategy lead for health authority interactions on assigned programs, including FDA and ex-U.S. regulatory agency interactions. Provide strategic guidance on regulatory pathways, submission strategies, expedited programs, scenario plans, and risk mitigation plans Lead the preparation, review, and submission of regulatory documents, including INDs, IND amendments, CTAs, briefing packages, meeting requests, annual reports, and other assigned regulatory applications. Represent Regulatory Affairs on cross-functional program teams and provide regulatory leadership across Clinical, Nonclinical, CMC, Quality, and Commercial functions. Drive regulatory timelines and ensure high-quality, compliant submissions aligned with corporate objectives. Build and maintain strong working relationships with regulatory agencies and external partners for assigned programs, including regulatory CROs, consultants, and alliance or business partners as applicable. Monitor evolving global regulatory