Sr. Director, Regulatory Affairs

All Jobs  >  Sr. Director, Regulatory Affairs Apply Sr. Director, Regulatory Affairs Cambridge, MA Apply Description Sr. Director, Regulatory AffairsAt 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 ResponsibilitiesLead 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 plansLead 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 requirements and assess potential impact on assigned development programs to guide business strategy.Contribute to organizational growth, process improvements, and development of regulatory infrastructure and best practices.Mentor and support junior regulatory team members as the organization continues to scale. Requirements  QualificationsBachelor’s degree required; advanced degree (MS, PharmD, PhD, MD, or equivalent) preferred.Minimum of 10 years of regulatory affairs experience within biotechnology and/or pharmaceutical industry, with at least 5 years in leadership role(s).Strong experience supporting      regulatory strategy and submissions across multiple stages of development.Demonstrated success leading FDA  or equivalent Health Authority interactions and major regulatory      submissions.Experience with global clinical trial applications inclusive of China, Europe, and/or Australia preferred.Experience in rare disease, immunology, nephrology, infectious disease, or related therapeutic areas preferred.Deep understanding of global regulatory requirements and drug development processes.Strong communication,...