Director Of Regulatory Affairs Jobs in Boston, MA

Kymera Therapeutics

$160000 - $275000

Watertown, MA

Having advanced the first degrader into the clinic for immunological diseases, Kymera is focused on building an industry-leading pipeline of oral small molecule degraders to provide a new generation of convenient, highly effective therapies for patients with these conditions. As a critical member of a growing RA organization, this role will leverage their recent and relevant hands-on experiences developing immunology treatments to help rapidly advance Kymera's I/I portfolio of targeted protein degraders.

Monte Rosa Therapeutics, Inc

Boston, Massachusetts

Overview: Monte Rosa Therapeutics is seeking an experienced and strategic Director of Regulatory Affairs to lead and support global regulatory efforts across our development programs, with a focus on immunology. Lead the preparation, submission, and maintenance of regulatory applications, including INDs, CTAs, marketing applications, Annual Reports, Orphan Drug Designation, Requests for Fast Track, and other regulatory documents.

Clinical Dynamix, Inc.

Watertown, MA

The Associate Director or Director of Regulatory Affairs will be a key member of the STAT6 Regulatory team working in partnership with the Global Program Regulatory lead to develop and execute on innovative and creative global regulatory strategies. As a critical member of a growing RA organization, this role will leverage their recent and relevant hands-on experiences developing immunology treatments to help rapidly advance Company’s I/I portfolio of targeted protein degraders.

Beth Israel Lahey Health

Boston, MA

Collaborates with the central BILH Information Systems department to ensure adequate electronic systems are in place to capture the data required for submission to regulatory required registries such as UNOS, SRTR, the Joint Commission and INTERMACs. The Manager of Business and Regulatory Affairs oversees financial performance, regulatory compliance, and data management of the Heart Transplant, LVAD and ECMO programs and programs related to Advanced Heart Failure.

Software Galaxy Systems, LLC

Cambridge, MA

Co-lead strategic approval of grants, sponsorships, and memberships (e.g., independent medical education grants, non-educational grants, medical sponsorships, corporate memberships) and serve as a voting member of the review team. Oversee daily operational and project management activities associated with educational grants and Medical Affairs sponsorship processes (e.g., intake, review, tracking, scope changes, reconciliation, closeout, and.

Azurity Pharmaceuticals - US

Woburn, MA

Development and implementation of clinical regulatory strategies and tactics,including but not limited to, Modeling Informed Drug Development (MIDD), real- world data (RWD)/real-world evidence (RWE), and meta-analysis, for pipeline and commercial assets,while considering FDA and other health authority clinical and regulatory requirements. As a part of the Regulatory Affairs team at Azurity, the Regulatory Affairs Director – Clinical Strategy will conduct in depth analysis of regulatory and clinical information to develop complex strategies supporting potential drug products for development and commercial drug products for expansion of the Azurity portfolio of medications.

Kura Oncology

$226495 - $258817

Boston, MA

Enrollment in a Phase 2 registration-directed trial of ziftomenib in R/R NPM1-mutant AML has been completed, and in the second quarter of 2025, the companies announced the FDA's acceptance of a New Drug Application for ziftomenib for the treatment of adult patients with R/R NPM1-mutant AML and assignment of a Prescription Drug User Fee Act target action date of November 30, 2025. Ziftomenib, a once-daily, oral menin inhibitor, is the first and only investigational therapy to receive Breakthrough Therapy Designation from the U.S. Food and Drug Administration ("FDA") for the treatment of relapsed/refractory ("R/R") NPM1-mutant acute myeloid leukemia ("AML").

Avalyn Pharma

$163000 - $182000

Boston, MA

This is a critical role for a highly motivated regulatory leader with experience in rare disease drug development, combination products, and a proven track record of advancing programs from early stages through late-phase clinical development. Avalyn is reimagining the future of pulmonary fibrosis treatment with a pipeline of new inhaled formulations of approved medicines designed to reduce systemic exposure and deliver medication directly to the site of disease.

Akebia Therapeutics

$246330 - $333270

Cambridge, MA

This is a highly visible and impactful position, offering the opportunity to influence development programs from early through late-stage, guide key regulatory interactions, and help bring meaningful therapies to patients with significant unmet need. At Akebia we take that number very seriously and every day we come to work, with the purpose of bettering the lives of each person impacted by kidney disease and the renal community that serves them.

Chemours

$169344 - $264600

Boston, MA

The responsibilities of the position include, but are not limited to, the following: + Demonstrate a high degree of knowledge about the political, economic, and social factors affecting public policy decision making; how engagement with government officials can lead to the enactment of new or the modification of existing regulations; implement policies and take other governmental actions that are favorable to Chemours’ business growth, corporate well-being, and the industry sectors in which the company operates. The successful candidate will join Chemours’ Global Government Affairs Group with a primary responsibility for supporting U.S. federal regulatory affairs engagement with the United States Environmental Protection Agency (USEPA), as well as other select federal administrative agencies; key trade organizations that help shape regulatory policies at the U.S. federal level; and members of the U.S. Congress and their staffs.

United Therapeutics

$165000 - $225000

Boston, MA

12+ years of biologic or pharma regulatory experience with a Bachelor's Degree in life sciences, quality, regulatory affairs or a related area of study or 10+ years of biologic or pharma regulatory experience with a Master's Degree in life sciences, quality, regulatory affairs or a related area of study or 7+ years of biologic or pharma regulatory experience with a PhD in life sciences, quality, regulatory affairs or a related area of study. We are focused on the research and development of transplantable kidneys ( mirokidney® ), livers ( miroliver® ), and a bioengineered external liver assist device for acute liver failure ( miroliver_ELAP_® ), with plans to also bioengineer other critical organs like lungs, pancreases and hearts.

Relay Therapeutics

Cambridge, MA

Built on unparalleled insights into protein motion and how this dynamic behavior relates to protein function, we aim to effectively drug protein targets that have previously been intractable, with an initial focus on enhancing small molecule therapeutic discovery in targeted oncology. You will work side by side with your regulatory and research and development colleagues to develop​ and execute innovative regulatory strategies for our fast-paced programs, including the implementation of non-clinical and clinical regualtory strategy for relevant products.

AVEO Oncology

Boston, MA

The Executive Director, Global Regulatory Affairs will provide strategic and operational leadership for global regulatory activities across the company’s oncology portfolio and will be accountable for the development and execution of integrated global regulatory strategies across the full product lifecycle, from early clinical development through registration, commercialization, and post‑approval lifecycle management. Ensure the preparation, review, and approval of high‑quality regulatory submissions and related documentation, including but not limited to INDs/CTAs, scientific advice packages, orphan drug applications, PIPs/PSPs, BLAs/MAAs, labeling strategy and negotiations, responses to regulatory questions, and post‑approval commitments.

Candel Therapeutics

Needham, MA

The Associate Director/Director, Regulatory Affairs CMC will serve as the CMC regulatory lead for one or more viral vector-based gene therapy programs across the product lifecycle, from preclinical development through clinical trials, marketing application (BLA/MAA), and post-approval lifecycle management. This individual, in collaboration with cross-functional stakeholders, will develop and execute global CMC regulatory strategies, author and review CMC sections of regulatory submissions, and serve as a key liaison with health authorities on manufacturing, analytical, and quality matters.

Candel Therapeutics

Needham, MA

Experience with gene therapy, cell therapy, or other ATMP products, including familiarity with EMA’s CAT (Committee for Advanced Therapies) review pathway, ATMP classification, and the distinct regulatory considerations for these modalities (e.g., long-term follow-up requirements, conditional marketing authorization, hospital exemption frameworks). Lead the preparation of global regulatory submission plans, including sequencing and interdependencies across INDs/CTAs, Orphan Drug Designations, Pediatric Study Plans/PIPs, Breakthrough Therapy / PRIME / Innovation Passport designations, and marketing applications.

Ironwood Pharmaceuticals

Boston, MA

Coordinate, review, and be accountable for the quality and timeliness of global CMC regulatory submissions and lifecycle filings, including original INDs, CMC amendments, IMPD amendments, annual reports, meeting requests, briefing packages, marketing applications, and post-approval changes. Lead preparation of high-quality CMC briefing packages and regulatory narratives for health authority meetings, including definition of regulatory positions, risk mitigation strategies, and alignment of supporting data; participate in or lead agency interactions as a key spokesperson.

Beam Therapeutics

$130000 - $190000

Cambridge, MA

Beam's suite of gene editing technologies is anchored by base editing, a proprietary technology that is designed to enable precise, predictable and efficient single base changes, at targeted genomic sequences, without making double-stranded breaks in the DNA. Serve as Regulatory lead for PRC/MLR review of promotional, disease awareness, scientific exchange, HCP, and patient-directed materials for certain products, under the supervision of the Director of Regulatory Labelling.

Kymera Therapeutics

$235000 - $330000

Watertown, MA

Responsibilities include building strong collaborative partnerships with asthma key opinion leaders (KOLs) and scientific organizations, providing medical and scientific expertise for portfolio indications, and supporting data generation and dissemination, scientific publications, and advisory boards. Having advanced the first degrader into the clinic for immunological diseases, Kymera is focused on building an industry-leading pipeline of oral small molecule degraders to provide a new generation of convenient, highly effective therapies for patients with these conditions.

Bradsby Group

Boston, MA

The primary responsibilities encompass representing the company in the shared governance process to optimize our asset value by advocating for market evolutions that foster competition in the wholesale energy market, working with internal stakeholders to define and resolve issues within the RTO footprint and supporting business development for future projects. This position will be responsible for helping to execute, manage, monitor and coordinate the regulatory strategy and advocacy within the New York and New England markets.

Werfen

Bedford, Massachusetts

Lead field corrections and removal for on-market products, determining classification and regulatory agency reportability based on assessed risk, preparing comprehensive regulatory strategy, authoring field communication, leading cross-functional team to ensure timely customer notification, reporting and interfacing with regulatory agencies (as required), and supervising the regulatory team that assembles and maintains the necessary support records. This leadership role owns all elements related to post-market regulatory compliance to meet worldwide regulatory requirements, including vigilance reporting, recall (product correction and removal) management, on-market product change assessment, and the post-market surveillance (PMS) program.

Monte Rosa Therapeutics, Inc

Boston, Massachusetts

Researches and analyzes regulatory information and determines acceptability of data, procedures, and other product-related documentation presented in support of product registration. Under supervision, compiles regulatory submissions, license renewal and annual registrations to the US Food and Drug Administration (FDA) and other regulatory agencies.

Beam Therapeutics

$155000 - $190000

Cambridge, MA

Beam's suite of gene editing technologies is anchored by base editing, a proprietary technology that is designed to enable precise, predictable and efficient single base changes, at targeted genomic sequences, without making double-stranded breaks in the DNA. In partnership and under guidance from the Regulatory Lead, drive the development of global regulatory strategy for Beam's portfolio of advanced genetic medicines and ensure integration of regulatory tactics that support the broader corporate strategy.

Axon

$110070 - $176112

Boston, MA

In addition to the specific requirements listed below, the Senior Manager should be highly motivated, enjoy working in a fast-paced and often changing environment, have the ability to learn quickly, and be adept at setting priorities and anticipating needs. You will be a representative of Axon and lead meetings with state, city and county government officials to advance Axon's position with relevant government and law enforcement stakeholders, as well as to drive broader awareness and support for Axon's mission.

LeMaitre

$95000 - $125000

Burlington, Massachusetts

Provide support to currently marketed products including: reviewing of engineering change orders, labeling, promotional material, product changes and documentation for changes requiring regulatory approval. Candidate will prepare regulatory submissions for new products/product changes to ensure timely approval for market release and will follow up with regulatory agencies on these submissions.

TechDigital Corporation

Danvers, MA

Description/Comment: The Medical and Scientific Affairs function provides leadership and direction on medical, scientific and clinical decisions related to the overall Leica Biosystems business strategy. Partner with internal and external resources to deliver MSL and Medical Director effectiveness, Medical insights generation, and reporting on key projects.

TalentBurst, Inc.

Marlborough, MA

Establishes and leads programs comprised of multiple projects, including designing how information is rolled up and cascaded down, operating rhythms and mechanisms, and tracking against the integrated set of milestones and deliverables. Knowledge: • Demonstrated experience leading large or complex projects with multiple workstreams from initiation to completion (7-10 years experience).

Rhythm Pharmaceuticals

Boston, MA

At Rhythm we are dedicated to transforming the lives of patients living with rare neuroendocrine diseases by rapidly advancing care and precision medicines that address the root cause. This role involves managing the preparation of eCTD submission-ready documents, coordinating across functions, and ensuring quality, accuracy, and adherence to regulatory guidelines.

Akebia Therapeutics

$165543 - $223969

Cambridge, MA

Responsibilities include but are not limited to the following: Plans and manages USPI and CCDS creation, maintenance, distribution, tracking and implementation to ensure documents are produced in a timely manner according to internal operating procedures and external regulatory requirements. At Akebia we take that number very seriously and every day we come to work, with the purpose of bettering the lives of each person impacted by kidney disease and the renal community that serves them.

AVEO Oncology

Boston, MA

Reporting to the CEO/CMO the Head of Medical Affairs will serve as the functional manager and leader of the Field-based Medical Science Liaison team and provide strategic input into key medical affairs activities, including consistent and aligned medical and scientific communications, cross-functional medical strategy, development and execution of Advisory Boards, KOL and other key customer identification and engagement, publication strategy and planning, CME topics of interest and grant administration, and fostering relationships with key societies, physician networks, oncology cooperative groups and academic institutions. · Support and train the team in engaging in compliant scientific exchange about current and emerging therapies, discussions around investigator-initiated trials, and in delivering effective presentations; provide appropriate mentoring and coaching to direct reports with respect to technical skills, business acumen/planning, and effective regional and time management, including frequent field visits with the MSL team.

City of Boston

Boston, Massachusetts

Serving as the Environment Department’s lead on climate policy, the Director will carry out and/or oversee four key functions: climate policy development and engagement with state and Federal policymakers and regulators; delivery of a portfolio of high-priority climate and sustainability special projects; oversight of energy utility collaboration on policy matters; and Department-wide guidance and support on legislative and policy strategy. The Director is a leader in energy, GHG mitigation, and environmental policy for the City and advises the Department, Chief Climate Officer, Climate Council, all agencies in the City, and stakeholders on legislation, policy, and regulation that affect and advance City goals.

Clear Ballot Group

Nashua, NH

Collaborate with product, engineering, and operations teams to develop long-term certification roadmaps, determining which product versions and state certifications to pursue and prioritize. Great elections require secure and reliable tabulation equipment, full transparency of the process in which ballots are created and cast, and the ability to audit the results.

Werfen

$215000 - $260000

Bedford, Massachusetts

Financial stewardship is central to the role, encompassing cost avoidance strategies, service pricing models - including service contract pricing - and workload optimization through field area and territory mapping. Additionally, this role plays a critical part in supporting new product introductions and product life-cycle management, ensuring service readiness and operational integration throughout the product journey.

Michael Page

$165000 - $195000

Bedford, MA

This role leads all regulatory affairs and quality assurance functions, ensuring global compliance and driving continuous improvement across the organization. Manage daily RA/QA operations including CAPA, risk management (ISO 14971), document control, training, and quality metrics.

Werfen

$200000 - $245000

Bedford, Massachusetts

Inclusive of Commercial Marketing, Market Surveillance, Sales Business Partnership, Implementation and Post Sales Technical Support as it relates to IT focused product functionality, solutions, solution architecture and cybersecurity. Develops and maintains applicable business and regulatory policies/procedures/work instructions; ensures organizational compliance with all Quality, Regulatory, Service & Support policies, procedures, work instructions and records, ensuring all records are compliant, complete and accurate.

GD Resources

Acton, MA

In addition, this role will be responsible for overseeing the statistical analysis of clinical study data ensuring appropriate statistical methods and accurate analyses to evaluate efficacy and safety and answer research related questions. Support the design of clinical studies and ensure accurate interpretation of clinical study data working cross functionally to ensure the needs of the business are met.

TalentBurst, Inc.

$70 - $75

Cambridge, MA

Exposure to Starting Point templates, SharePoint, EndNote, and Toolbox Pharma preferred " Alignment with *** Core Values: Commitment to People, Fiercely Innovative, Purposeful Urgency, Open Culture, and Passion for Excellence. " Bachelor's degree in a relevant scientific/technical field or equivalent experience 4+ years of biotech/pharma or CRO experience in document QC and electronic publishing within a regulatory environment.

Beth Israel Lahey Health

Boston, MA

This position is responsible for administrative and coordinating functions pre- and Post accreditation surveys (Application, communicates with service line leads regarding action plan and next step in preparation for or following inspection surveys, coordinates response assessment dashboards, and MOS Design, etc.), as well as other large-scale quality and safety survey coordination and compliance. Acts as project resource and partners with the project managers, data abstractors, data analysts, and other hospital staff to create and customize tools and media regarding accreditation requirements to identified members of the BIDMC community and clinical affiliates.

Boston University

$100000 - $115000

BOSTON, MA

Reporting directly to the Vice President, Financial Operations, this role requires an experienced professional with a thorough understanding of Generally Accepted Accounting Principles and the awareness of the micro and macro-economic trends that influence the higher education industry. Preferred Skills: CPA or CFA certification(s) Benefits/Other Information: Boston University's generous benefits package includes health, dental, life insurance, and paid time off as well as potential remote working arrangements!

Boston University

$62525 - $81175

BOSTON, MA

Major duties of this position include: Daily management of areas relating to banking and investment activities, which include reviewing the status of the University's bank and investment accounts, moving cash for domestic and international payments, executing University debt service payments, documenting processes, and maintaining payment workflow and record storage system. The Treasury Analyst is a key member of the Debt, Treasury, and Risk Management team at Boston University, and works closely with internal customers from Budget, Business Affairs, Student Accounts, and Research Accounting, and collaborates with other external banking partners.

Olympus Corporation of the Americas

Westborough, MA

Clinical Research: To support the Global Head of Clinical Affairs in the conception, development, and implementation of impactful clinical investigations to arrive at relevant study designs by providing applied medicine therapeutic expertise to the clinical team (e.g., practice insights, care delivery, clinical impact assessments, and intended therapeutic benefit). This role requires the application of prior clinical knowledge and medical training to lead internal stakeholders within the Gastroenterology therapeutic area while simultaneously demonstrating proficiencies in external scientific engagement via peer-to-peer consultations with physicians, payors, professional societies, patient advocacy groups, as well as health system and integrated delivery networks worldwide.

Circle

$235000 - $290000

Boston, MA

Circle’s platform includes the world’s largest regulated stablecoin network anchored by USDC, Circle Payments Network for global money movement, and Arc, an enterprise-grade blockchain designed to become the Economic OS for the internet. This role sits at the center of Circle’s engagement with the largest, most complex financial institutions in the world and is critical to advancing USDC’s role in regulated payments, liquidity, treasury, and emerging on-chain financial infrastructure.

Ardelyx, Inc.

$183000 - $210000

Waltham, MA

This role will be responsible for collaborating with multiple cross-functional stakeholders, including but not limited to HCP Marketing, Patient Advocacy, Market Access, Market Research, Sales, Regulatory, Medical Affairs, Commercial Operations, Legal, and Commercial leadership. Lead the creation and implementation of various innovative direct-to-patient marketing strategies and tactics across marketing channels (print, digital, SEO/SEM, point of care, social media, broadcast, video).

Artech LLC

$100 - $107

Boston, MA

The Associate Director, Epidemiology is a high-level strategic and scientific role accountable for developing, coordinating, and executing cutting-edge, effective, and impactful epidemiology deliverables within the Neurology/Ophthalmology therapeutic area with a focus on post-approval studies including rare disease registries. Through partnerships within cross-functional teams, this role ensures appropriate epidemiological perspective is provided in support of strategic needs and integrated into Alexion- AstraZeneca Rare Disease Unit s corporate plans.

Thea Pharma Inc.

$150000 - $210000

Waltham, MA

Thea Pharma markets a suite of leading eye-care drugs that have been approved by the U.S. Food and Drug Administration (FDA), including iYUZEH, Zioptan®, Cosopt®, Cosopt® PF, Azasite®, Akten®, and Betimol®, as well as AcellFX Acellular Amniotic Membrane and the portfolio of iVIZIA dry-eye drops and eyelid hygiene products. By focusing its parent company’s passion and expertise within the U.S. market, Thea Pharma’s goal is to deliver uncompromising care that enables all stakeholders to envision the future of ophthalmic treatment with eyes wide open.

Naveris

Waltham, MA

This role requires a leader with deep oncology diagnostics experience, proven success leading teams through expansion and change, and the ability to drive adoption across multidisciplinary oncology care teams, including Otolaryngology (Head & Neck Surgeons), Medical Oncology, Radiation Oncology, and Colorectal Surgeons. Naveris, a commercial stage, precision oncology diagnostics company with facilities in Boston, MA and Durham, NC, is looking for a Area Sales Director to help us advance our mission of developing and delivering novel diagnostics that transform cancer detection and improve patient outcomes.

Ardelyx, Inc.

$257000 - $314000

Waltham, MA

The ideal candidate is a dynamic, strategic marketer with deep experience in biotech or specialty pharmaceuticals, a proven record of successful product leadership, and the ability to inspire and guide a cross-functional team. This leader will evolve the brand’s vision and strategic focus, drive integrated marketing efforts, and oversee the thought leader engagement strategy, ensuring cohesive communication across healthcare professionals (HCP), patients and the broader medical community.

Beam Therapeutics

$185000 - $225000

Cambridge, MA

Reporting to the Director of Contracts & Compliance, this role provides pragmatic, risk-balanced legal support, partners closely with cross-functional stakeholders, and helps strengthen contracting infrastructure as the company advances toward commercial-stage operations. Beam's suite of gene editing technologies is anchored by base editing, a proprietary technology that is designed to enable precise, predictable and efficient single base changes, at targeted genomic sequences, without making double-stranded breaks in the DNA.

Beam Therapeutics

$210000 - $260000

Cambridge, MA

This role will serve as a strategic partner to Marketing, Market Access, Patient Operations, Medical Affairs, and Portfolio Strategy to translate key business questions into actionable insights that inform decision-making across the product lifecycle. Beam's suite of gene editing technologies is anchored by base editing, a proprietary technology that is designed to enable precise, predictable and efficient single base changes, at targeted genomic sequences, without making double-stranded breaks in the DNA.

Beam Therapeutics

$260000 - $320000

Cambridge, MA

Provide operational oversight of Medical Affairs evidence generation, including vendor/CRO governance, milestone/deliverable tracking, data‑quality plans, risk management, and on‑time execution across Medical Affairs–led studies; contribute to long‑term capability building (digital health, real‑world studies). Support business decisions around ex-US strategy including, but not limited to, scoping ex-US opportunities, prioritizing country engagement, early scientific advice / parallel consultations with EMA and HTA bodies (e.g., HTACG/JSC), providing advice to development programs on endpoint selection to support product and reimbursement approvals ex-US, etc.

Humana

$168000 - $231000

Boston, MA

The Director of State Public Policy role resides within the Government Affairs Department and will serve as an expert in pharmacy and pharmacist licensure, pharmacy shared services, occupational/facility licensure, PBM, and federal healthcare preemption public policy at the state level while working with subject matter experts and business units across the Humana enterprise. + Represent Humana before national advocacy groups, trade associations, public policy organizations, intergovernmental groups, and state boards of pharmacy/National Associations of Boards of Pharmacy; manage public policy consultants and develop external stakeholder outreach strategies.