Sr. Director, Regulatory Affairs at Merida Biosciences

Cambridge, Massachusetts, United States -

Full Time

Start Date

Immediate

Expiry Date

11 Sep, 26

Salary

300000.0

Posted On

13 Jun, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Strategy, Health Authority Interactions, FDA Submissions, IND Preparation, Global Regulatory Requirements, Clinical Trial Applications, Cross-functional Leadership, Risk Mitigation, CMC, Pharmacovigilance, Biotechnology, Drug Development Process

Industry

Biotechnology Research

Description

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 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 Qualifications Bachelor’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, leadership, and influencing skills with the ability to work effectively across functions and levels. Proven ability to thrive in a dynamic, fast-paced biotech environment. Compensation: We understand that compensation is an important part of considering a new opportunity. Our goal is to be transparent so there are no surprises at the end of the process, and you can feel confident that your offer is both fair and equitable. To support that, we’re sharing our hiring range for this role upfront: typically for the Sr. Director level we target $245,000 to $300,000 . The final offer will take into account a number of factors, including your skills, experience, location, market data, and internal equity. Along with a competitive salary, we’re proud to offer a comprehensive benefits package designed to support you both personally and professionally. Merida Biosciences is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law. Note to Employment Agencies: Please do not forward any agency resumes. The company will not be responsible for any fees related to resumes that are unsolicited

Responsibilities

Lead and execute global regulatory strategies for development programs from early stages through commercialization. Serve as the primary regulatory lead for interactions with the FDA and other international health authorities.