Cambridge, Massachusetts, United States · On-site
$245k–$300k/yr
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 be…
Skills: Regulatory Strategy, Health Authority Interactions, FDA Submissions, IND Preparation, Global Regulatory Requirements
Cambridge, Massachusetts, United States · Hybrid
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Cambridge, Massachusetts, United States · Hybrid
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The Senior Legal Director, R&D and Regulatory Counsel is a strategic legal leader who enables efficient, high-quality decision-making on regulatory pathways, product development, and lifecycle management. This role provi…
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Cambridge, Massachusetts, United States · Hybrid
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The Senior Legal Director, R&D and Regulatory Counsel is a strategic legal leader who enables efficient, high-quality decision-making on regulatory pathways, product development, and lifecycle management. This role provi…
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Cambridge, Massachusetts, United States · Hybrid
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Cambridge, Massachusetts, United States · On-site
Company Description By working at Harvard University, you join a vibrant community that advances Harvard's world-changing mission in meaningful ways, inspires innovation and collaboration, and builds skills and expertise…
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Cambridge, Massachusetts, United States · Remote OK
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Cambridge, Massachusetts, United States · Remote OK
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Cambridge, Massachusetts, United States · Hybrid
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Cambridge, Massachusetts, United States · On-site
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Cambridge, Massachusetts, United States · Hybrid
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Job Description Summary #LI-Hybrid Internal Title: Director Location: Cambridge, MA Novartis is a leader in mechanistic modelling and simulation. We are seeking an experienced modelling and simulation leader to build and…
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Cambridge, Massachusetts, United States · Remote OK
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Associate Director, Competitive Intelligence & Market Research, Commercial Operations & Analytics Who We Are At Agios, we are fueled by connections to transform rare diseases. We foster an inclusive, collaborative cultur…
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Cambridge, Massachusetts, United States · On-site
A bit about us Trek is an awesome place to work, with amazing benefits for all employees. We build only products we love, provide incredible hospitality to our customers, and change the world by getting more people on bi…
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Cambridge, Massachusetts, United States · Hybrid
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By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice an…
Skills: Clinical Development Strategy, Medical Monitoring, Protocol Development, Regulatory Affairs, Matrix Team Leadership
Cambridge, Massachusetts, United States · Hybrid
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By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice an…
Skills: Clinical Development Strategy, Psychiatry Expertise, Medical Monitoring, Protocol Development, Regulatory Affairs
Cambridge, Massachusetts, United States · Remote OK
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Cambridge, Massachusetts, United States · Remote OK
$190k–$233k/yr
Why Join Intellia? Our mission is to develop curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases. Beyond our science, we live our four cor…
Skills: Medical Communications, Congress Planning, Stakeholder Management, Project Management, Vendor Management
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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.
Requires a bachelor's degree and at least 10 years of regulatory affairs experience in biotech or pharma, including 5 years in leadership. Proven success in leading major regulatory submissions and health authority interactions is essential.
Description
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.
Requirements
Qualifications
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
Merida Biosciences is a biotechnology company pioneering a new class of precision therapeutics designed to selectively and durably eliminate pathogenic antibodies that drive disease. The company is advancing a robust pipeline to precisely eliminate the root cause of multiple autoimmune and allergic conditions that are inadequately treated today. Its lead program is designed to specifically and rapidly clear the pathogenic autoantibodies that cause Graves' disease, an autoimmune disorder that affects the thyroid gland. Merida was publicly launched in April 2025 and is based in Cambridge, MA. For more information about Merida, visit www.meridabio.com.
Offices: 500 Technology Sq, Cambridge, Massachusetts 02139, US
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