3,542 Results for

Regulatory Manager Jobs in Massachusetts

Jobs

Sr. Manager Regulatory Affairs CMC Alnylam Pharmaceuticals Inc

Cambridge, MA

$144,400–$195,400 / year

Helps to lead the interpretation of regulatory expectations for emerging modalities, including: siRNA and oligonucleotide therapeutics Conjugated delivery systems (e.g., GalNAc and other targeting ligands including biologic modalities) Complex drug substance and drug product configurations Helps to assess CMC implications of new technologies and modalities, including: Impact on product characterization, control strategies, and specifications Regulatory classification considerations (e.g., small-molecule vs biologic paradigms) Manages regulatory compliance activities including periodic regulatory reporting, review of technical documents, and providing regulatory assessments. Broad understanding of: Drug substance and drug product development Analytical characterization and control strategies Regulatory framework across major regions (e.g., US, EU, Japan, China) Strong ability to integrate scientific, technical, and regulatory considerations into clear strategies #LI-KB1 #LI-Hybrid U.S. Pay Range $144,400.00 - $195,400.00 The pay range reflects the full-time base salary range we expect to pay for this role at the time of posting.

30+ days ago

Senior Manager, Regulatory Affairs Kymera Therapeutics

Watertown, MA

$145,000–$215,000 / year

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. Reporting to the Director of Regulatory Affairs, the Senior Manager will independently lead regulatory activities at the study level, acting as the regulatory representative on cross-functional teams while driving execution of program regulatory strategies.

21 days ago

Senior Manager Regulatory Affairs Chemistry Manufacturing and Controls CMC AbbVie Inc

Waltham, MA

Represents CMC regulatory affairs on teams such as the product development, Global Regulatory Product Teams and Operations brand teams, for assigned projects; negotiates with and influences team members with support of management to maximize chances for first pass approval of regulatory submissions. The Senior Manager Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) works with internal and external partners to deliver products to patients to deliver biologics products to patients, including mAb, ADC and cell & gene therapies.

23 days ago

Manager, Regulatory Affairs Monte Rosa Therapeutics, Inc

Boston, Massachusetts

Full time

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.

30+ days ago

Manager, Regulatory Affairs Deciphera Pharmaceuticals Inc

Waltham, MA

$116,000–$160,000 / year

The Manager, Regulatory Affairs will partner cross-functionally to support high-quality regulatory submissions and help drive successful interactions with global health authorities. Our base salary is just one component of Deciphera's competitive total rewards strategy that also includes annual performance bonus, a long-term incentive plan, full range of benefits and other incentive compensation plans (if applicable).

30+ days ago

Senior Manager, Regulatory Affairs Getinge AB

Boston, MA

Remote

The Senior Manager, Regulatory Affairs, provides regulatory strategy and execution leadership for U.S., EU, and Rest of World (ROW) market access and compliance to enable safe, compliant market access for a broad Surgical Workflows Infection Control Consumable (SWICC) products portfolio, including a wide range of infection control consumables, while also supporting capital equipment such as sterilizers, washer-disinfectors, ultrasonic equipment, surgical lights, and operating tables. Serve as Regulatory Affairs authority in cross-functional product development teams, ensuring regulatory requirements are embedded in design controls, technical documentation, risk management (ISO 14971), labeling, and verification/validation planning, with accountability for U.S. (FDA), EU MDR, and applicable ROW regulatory decision-making.

21 days ago

Manager, Regulatory Affairs Advertising & Promotion (Work from Home) Parexel

Massachusetts

This individual will act as a trusted advisor, collaborating across cross-functional teams within a large, dedicated client partnership—helping to influence regulatory strategy and deliver meaningful impact, all while working remotely. This role extends beyond execution, requiring a proactive leader who can independently review materials, interpret evolving FDA guidance, and pivot regulatory strategy to support business objectives while mitigating risk.

25 days ago

Senior Manager, Regulatory Affairs Kymera Therapeutics Inc

Watertown, MA

$145,000–$215,000 / year

29 days ago

Manager, Regulatory Affairs Monte Rosa Therapeutics Inc

Boston, MA

30+ days ago

Senior Manager, Regulatory Affairs, Operations Xenon Pharmaceuticals

Needham, Massachusetts

Our Phase 3 epilepsy program also includes a second FOS study, X-TOLE3, which would support regulatory submissions outside the U.S., and the X-ACKT study in primary generalized tonic-clonic seizures, which would support regulatory submissions for an additional epilepsy indication. Our Total Rewards program includes base salary, target bonus, and stock options, as well as a full range of benefits including medical, dental, vision, short-& long-term disability, accidental death & dismemberment, and life insurance programs, Employee Assistance Program, travel insurance, and retirement savings programs with company matching contributions.

30+ days ago

Assistant Casino Regulatory Manager, MGM Springfield Commonwealth of Massachusetts

Springfield, MA

Manager'',''United States-Massachusetts-Springfield-115 State Street'',''United States-Massachusetts-Springfield-115 State Street'',''Public Safety'',''Public Safety'',''Massachusetts Gaming Commission'',''Massachusetts Gaming Commission'',''Full-time'',''Full-time'',''Day'',''Day'',''Jun 1, 2026, 3:50:22 PM'',''Jun 1, 2026, 3:50:22 PM'',''1'',''1'',''116,000.00'',''96,000.00'',''116,000.00'',''Yearly'',''Kathleen Buckley'',''Kathleen Buckley'',''6179798461'',''000-Unclassified'',''000-Unclassified'',''No'',''No'',''Yes'',''Yes'',''false'',''1086775'',''1086775'',''true'',''1086775'',''false'',''Submission for the position: Assistant Casino Regulatory Manager, MGM Springfield - (Job Number: 2600043X)'',''false'',''1086775'',''false'',''true''. Experience, Education and Training: High school diploma or equivalent and 5-7 years of experience in process or project management, human resources, gaming, casino oversight, or a related field; Experience or exposure to mentoring or sponsoring others, creating workflows, and leading small team meetings; Or an equivalent combination of education and experience.

30+ days ago

Manager Regulatory Affairs-Chemistry Manufacturing & Controls CMC AbbVie Inc

Waltham, MA

Represents CMC regulatory affairs on teams such as the product development, Global Regulatory Product Teams and Operations Product Teams, for assigned projects; negotiates with and influences team members with support of management to maximize chances for first pass approval of regulatory submissions and stays abreast of regulatory procedures and changes in the external regulatory environment. Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of thisposting based on the job grade for this position.

30+ days ago

Regulatory Product Manager Acushnet Holdings Corp

Fairhaven, MA

$109,778–$139,783 / year

This role partners cross-functionally to monitor regulatory developments, assess risk, and ensure product compliance requirements are effectively integrated throughout the product lifecycle to support global market access and business growth. Bachelor's degree in Business, Supply Chain, Environmental Science, Regulatory Affairs, or a related field, with 8+ years of progressive experience in product compliance, product safety, regulatory affairs, or a related discipline.

18 days ago

Senior manager global regulatory affairs Katalyst Healthcares & Life Sciences

Boston, MA

This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to the team's delivery of critical functions as follows: This role is within in the GRA Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to the team's delivery of critical functions as follows. RA CMC member on the Global Regulatory CMC team may act as the delegate for the GRA CMC Product Lead at Regulatory, Pharmaceutical Development, and Commercial project teams throughout clinical development and commercial lifecycle.

30+ days ago

Manager, Regulatory Affairs Relay Therapeutics Inc

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. Your Role: You will work closely with research and development colleagues to support the development and execution of innovative regulatory strategies for programs ranging from first-in-human through late-stage clinical development, including the implementation of non-clinical and clinical regulatory strategy.

23 days ago

Senior Manager, Global Regulatory Affairs CMC Takeda Pharmaceutical Co Ltd

Boston, MA

$137,000–$215,270 / year

This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to the teams delivery of critical functions as follows: With some supervision, leads the execution of regulatory CMC investigational, registration and/or post-approval strategies for assigned products. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.

30+ days ago

Manager, Regulatory Affairs 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 closely with research and development colleagues to support the development and execution of innovative regulatory strategies for programs ranging from first-in-human through late-stage clinical development, including the implementation of non-clinical and clinical regulatory strategy.

21 days ago

Regulatory Product Manager Acushnet Company

Fairhaven, Massachusetts

This role partners cross-functionally to monitor regulatory developments, assess risk, and ensure product compliance requirements are effectively integrated throughout the product lifecycle to support global market access and business growth. Bachelor’s degree in Business, Supply Chain, Environmental Science, Regulatory Affairs, or a related field, with 8+ years of progressive experience in product compliance, product safety, regulatory affairs, or a related discipline.

15 days ago

Manager of Regulatory Compliance Signature Healthcare

Brockton, MA

Conducting detailed data analysis to identify trends, risks, and areas for improvement in regulatory compliance and patient safety, the Manager utilizes data to inform decision-making and develop actionable insights related to accreditation and payor contracts. We believe our distinctive Signature Healthcare team approach is the way healthcare should be: medical professionals across many locations communicating and collaborating, taking advantage of technologies and resources to make a difference in the lives and health of our patients.

30+ days ago

Senior Manager, Regional Regulatory Lead - North America, Seqirus Vaccines CSL Behring LLC

Waltham, MA

$154,000–$182,000 / year

The Senior Manager, Regional Regulatory Lead (RRL), North America Seqirus Vaccines in the Global Regulatory Strategy (GRS) team is a member of the GRA GRS Vaccines Therapeutic Area (TA) and contributes to the vision and goals of CSL as: Regulatory leader who leverages North America regulatory experience / expertise to actively contribute to an innovative, scientifically sound, global, integrated regulatory vision / strategies for assigned product/s with a patient centric-focus, leveraging regional commercial insights and applying prudent risk-taking to ensure timely delivery of successful regulatory outcomes. Regional expert regarding health authority requirements, regulatory filing pathway / categories, processes and ways of working and thus, can provide relevant guidance / assessment to internal stakeholders on means to address project challenges, leverage regulatory opportunities and advise on risk for developmental, new and marketed products.

30+ days ago

Sr. Manager, Technical Regulatory Compliance Johnson & Johnson

Raynham, MA

The position plays a critical role in managing compliance risk, supporting audit and inspection readiness, and enabling compliant execution of complex technical initiatives by partnering closely with Quality, Regulatory Affairs, Engineering, Manufacturing, and IT teams. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals.

30+ days ago

Regulatory Affairs Operations Manager Third Rock Ventures LLC

Cambridge, MA

for more information visit urlhttps://recruiting.paylocity.com/Recruiting/Jobs/Details/4004149.

30+ days ago

Sr. Manager/Associate Director, Regulatory Affairs Oruka Therapeutics

Waltham, California

Oruka’s mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice per year. This individual will work closely with cross-functional teams to provide regulatory guidance throughout product development, support health authority interactions, and help ensure the timely preparation and submission of high-quality regulatory applications.

30+ days ago

Senior Manager, Regulatory Lead Takeda Pharmaceutical Co Ltd

Boston, MA

$137,000–$215,270 / year

Assists in the creation and submission of high quality, compliant regulatory documents (e.g., BLAs, INDs, CTAs, MAAs, Variations/Supplements and other relevant regulatory filings such as PIPs/PSPs, ODDs, meeting requests and briefing packages) for assigned programs within defined timelines as per R&D and business objectives. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.

29 days ago

Sr. Manager/Associate Director, Regulatory Affairs Oruka Therapeutics Inc

Waltham, MA

$161,000–$187,000 / year

Oruka's mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice per year. This individual will work closely with cross-functional teams to provide regulatory guidance throughout product development, support health authority interactions, and help ensure the timely preparation and submission of high-quality regulatory applications.

30+ days ago

Regulatory Compliance Manager PGI Foods

Lowell, Massachusetts

$105,000–$125,000 / year
Full time

PGI Foods is seeking a Regulatory Compliance Manager to oversee regulatory programs that ensure our soups, sauces, and specialty food products meet all FDA, USDA, customer, and industry requirements. At PGI Foods, we're proud to manufacture high-quality soups, sauces, and specialty food products trusted by restaurants and retailers nationwide.

11 days ago

Digital Assets Regulatory Management Manager Deloitte Touche Tohmatsu Ltd

$144,600–$265,100 / year

Candidates joining our firm should possess an entrepreneurial drive, intellectual curiosity, creativity, and critical thinking in addition to the qualifications below: Strong oral and written communication skills, including the ability to support or lead business proposal development and sales presentations. As a Manager, you will have opportunities to: Oversee and direct end-to-end client projects focused on digital asset risk, regulatory compliance, and licensing, owning project scoping, resource allocation, timelines, quality, and deliverables.

30+ days ago

Senior CMC Regulatory Strategy Manager GSK plc

Waltham, MA

$144,375–$240,625 / year

GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients' needs and have the highest probability of success. Directs and communicates complex regulatory issues independently across the company and with external agencies and third parties as necessary, to influence project and policy issues that are aligned with business needs ensuring optimum position for the company.

30+ days ago

Manager, Regional Regulatory Lead - LCM CSL Plasma

Waltham, Pennsylvania

Regulatory leaders who leverage regional regulatory experience to actively contribute to an innovative, scientifically sound, global, integrated regulatory vision/strategies for assigned product/s with a patient-centric focus, leveraging regional commercial insights and applying prudent risk-taking to ensure timely delivery of successful regulatory outcomes. Developing regional knowledge regarding health authority requirements, regulatory filing pathway/categories, processes, and ways of working and thus, can provide relevant guidance / assessment to internal stakeholders (e.g., GRAST, GRL & Commercial) on means to address project challenges, leverage regulatory opportunities and advise on risk for developmental, new, and marketed products.

2 days ago

Senior Program Manager, Regulatory Delivery ESMP National Grid Plc

Waltham, MA

$105,000–$123,000 / year

Working within the New England Electric Engineering & Network Strategy organization, the Senior Program Manager, Electric Regulatory Delivery supports the delivery of the Company's Electric Sector Modernization Plan (ESMP) and related regulatory obligations. Support the development, compilation and editing of regulatory filings required to support ongoing regulatory processes including initial filings, discovery, testimony, and annual / semi-annual reports.

10 days ago

Senior Vice President, Regulatory Administration/Filings Manager The Bank of New York Mellon Corp

Westborough, MA

$102,000–$220,000 / year

In this role, youll make an impact in the following ways: Lead multiple teams of Regulatory Administration and Filings staff providing clients with legal guidance on SEC filings such as prospectuses, proxy statements, and board minutes. BNY Mellon can act as a single point of contact for clients looking to create, trade, hold, manage, service, distribute or restructure investments & safeguards nearly one-fifth of the world''s financial assets.

30+ days ago

System Quality & Regulatory Programs Manager UMass Memorial Health

Worcester, Massachusetts

Reporting directly to the SVP, Chief Quality Officer / Chief Clinical Informatics Officer, the System Quality & Regulatory Programs Manager provides enterprise‑level leadership and strategic oversight for quality, safety, and health equity regulatory programs across the UMMH system. This role builds and sustains strong collaborative relationships across all levels of the organization, working closely with clinical and administrative leadership, as well as quality managers and analysts at both the entity and system levels.

25 days ago

Sr Manager, Regulatory Compliance Staples Inc

Framingham, MA

The specific base pay may be influenced by a variety of factors to include the candidate''s experience, skill set, education, geography, business considerations, and internal equity. Our merchandising team aims to deliver the best value and selection to our customers through products, services and solutions all centered around our customers' needs.

29 days ago

Regulatory Reporting Manager Deloitte Touche Tohmatsu Ltd

$82,600–$162,800 / year

Manage end to end regulatory reporting activities covering 40 Act and non-40 Act funds in the investment management space (e.g., Form PF, TIC, CPO-PQR, Form 16, Form 13, N-PX, BEA reports), ensuring compliance with applicable regulatory requirements across various regulators such as SEC, CFTC, BEA, NFA, Treasury. We "embed continuous advantage" through domain, industry, technology and transformation skills to perform client business functions that manage risk and deliver value-added outcomes, all while driving predictable long-term revenue, profitability, and growth.

30+ days ago

System Quality /Regulatory Program/ Process Manager UMass Memorial Health Care Inc

Worcester, MA

$111,384–$200,491.20 / year

Reporting directly to the SVP, Chief Quality Officer / Chief Clinical Informatics Officer, the System Quality & Regulatory Programs Director provides enterprise‑level leadership and strategic oversight for quality, safety, and health equity regulatory programs across the UMMH system. This role builds and sustains strong collaborative relationships across all levels of the organization, working closely with clinical and administrative leadership, as well as quality managers and analysts at both the entity and system levels.

30+ days ago

Manager, Global Regulatory Operations Disc Medicine Inc

Massachusetts, MA

$128,000–$156,000 / year

IMPDs, meeting packages and CSRs), assisting with regulatory submission activities, performing Veeva RIM inputs, interacting with project team members and Regulatory vendors, authoring best practices and providing associated training as assigned, and other Regulatory Operations projects as needed. Prior experience with submission management and pre-publish compilation tasks for various IND submission types and subsequent post-publish eCTD review processes a plus.

30+ days ago

Applied AI Manager Regulatory Covington & Burling LLP

Boston, MA

$153,000–$228,000 / year

View Covington job applicant privacy notice here httpswww.cov.comenjob-applicant-privacy -notice access pursuant to US Export Control laws candidate must be either a a United States citizen or national b a person lawfully admitted for permanent residence of the United States i.e. Green Card" holder or c an INS-approved refugee or asylum holder who has applied for naturalization within six months of the date the individual first became eligible and if not yet naturalized is still actively pursuing naturalization if 2 years have passed since the date of application to be granted access pur suant to US Export Control laws. regulatory research horizon scanning advisory memos agency filings compliance support sufficient to translate attorney requirements into AI solutions familiarity Duties and Responsibilities Design build and maintain AI-enabled workflows and automation for regulatory analysis filings monitoring and advisory work including regulatory horizon scanning regulatory research advisory memo drafting support agency filing and submission workflows and compliance monitoring.

30+ days ago

Lead Environmental Regulatory Specialist/Project Manager Foth & Van Dyke LLC

$110,000–$130,000 / year

Support Client Managers with developing leads, expanding existing clientele, organizing marketing efforts, contributing to business development activities, assisting in preparation of request for qualifications / request for proposal (RFQ/RFP) response packages and making shortlist presentations. Oversee implementation of specialized projects that include coastal/waterfront development, docks and marinas, beach-dune system enhancement, inlet stabilization and maintenance, waterway improvements including shoreline stabilization structures, stormwater drainage systems, and environmental restoration projects.

24 days ago

Litigation Marketing Senior Manager - Regulatory Cooley LLP

Boston, MA

$170,000–$240,000 / year

Specific duties and responsibilities include, but are not limited to, the following: Position responsibilities: Strategic planning and leadership: In conjunction with the Associate Director or Director of Marketing (Business/Litigation), department and practice group leaders, develop and execute marketing and business development plans for assigned practice group(s)/industries/verticals, and individual partners within those groups. In this leadership role, the Senior Practice Group Marketing Manager will interact with practice group leaders and partners in devising marketing and client development programs in a manner consistent with the firm's overall strategy.

16 days ago

1940 Act Regulatory Administration Manager U.S. Bancorp

Boston, MA

$139,230–$163,800 / year

Serves as a resource on regulations and industry developments for fund customers in support of legal counsel and as a resource for internal related business lines with regard to matters concerning regulation of investment companies and industry developments. In addition, certain positions may also be subject to the requirements of FINRA, NMLS registration, Reg Z, Reg G, OFAC, the NFA, the FCPA, the Bank Secrecy Act, the SAFE Act, and/or federal guidelines applicable to an agreement, such as those related to ethics, safety, or operational procedures.

7 days ago

Manger, Transplant Quality & Regulatory Compliance Lahey Hospital and Medical Center

Boston, MA

$120,000–$150,000 / year

Actual compensation is determined based on several factors, that may include seniority, education, training, relevant experience, relevant certifications, geography of work location, job responsibilities, or other applicable factors permissible by law. In this role, the Manager, Transplant QAPI & Regulatory Compliance provides leadership for transplant quality assessment, performance improvement, patient safety, and regulatory compliance across hospital solid organ transplant programs.

30+ days ago

Manger, Transplant Quality & Regulatory Compliance Beth Israel Lahey Health

Boston, Massachusetts

Actual compensation is determined based on several factors, that may include seniority, education, training, relevant experience, relevant certifications, geography of work location, job responsibilities, or other applicable factors permissible by law. $120,000.00 USD - $150,000.00 USD The pay range listed for this position is the annual base salary range the organization reasonably and in good faith expects to pay for this position at this time.

30+ days ago

Regulatory Intelligence Manager KARL STORZ Endovision Inc

find description in this url https://career.karlstorz.com/job/Charlton-Regulatory-Intelligence-Manager-MA-01507/1410613433/ .

22 days ago

Director, Regulatory Affairs Liaison, Vaccines & Infectious Diseases Merck & Co Inc

Boston, MA

$210,400–$331,100 / year

Required Skills: Biological Sciences, Biostatistics, Clinical Judgment, Clinical Trial Planning, Clinical Trials, Communication, Cross-Functional Collaboration, Detail-Oriented, Infectious Disease, Leadership, Medical Writing, Pharmaceutical Regulatory Affairs, Pharmacovigilance, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Intelligence, Regulatory Issues, Regulatory Strategy Development, Regulatory Writing. Primary activities include, but are not limited to: Functions with a high degree of independence and provides regulatory oversight for assigned products, functioning as the single, accountable, global regulatory point of contact on those projects within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS.

24 days ago

Director, Business Development Regulatory Affairs Olympus Corp

Westborough, MA

Take responsibility for all RA aspects of each business development project by a) conducting or overseeing due diligence and integration activities, b) building a functional plan for each project to ensure that functional risks are identified, and actions are planned, and c) securing necessary approvals from RA/regional leadership for due diligence reports and integration strategy/plans. Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 5,200 employees throughout locations in North and South America.

15 days ago

Sr. Specialist, Regulatory Affairs LeMaitre

Burlington, Massachusetts

$110,000–$150,000 / year
Full time

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.

30+ days ago

Senior Director, Regulatory Affairs Skyhawk Therapeutics Inc

Waltham, MA

$270,000–$350,000 / year

We use our novel SkySTAR platform (Skyhawk Small molecule Therapeutics for Alternative splicing of RNA) to develop drug candidates directed toward targets for some of the world's most intractable diseases including neurological conditions, cancer, and traditionally "undruggable" targets. The Senior Director, Regulatory Affairs is responsible for planning, developing, and implementing regulatory strategy, submissions, and compliance activities for small molecule programs across early and late-stage development to support global regulatory approvals.

2 days ago

Director, Regulatory Affairs – Global Regulatory Strategy Monte Rosa Therapeutics, Inc

Boston, Massachusetts

Full time

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.

30+ days ago

Senior Regulatory Affairs Specialist Medtronic Plc

Danvers, MA

The Interventional Cardiology Therapies (ICT) portfolio provides innovative, minimally invasive cardiovascular technologies designed to help physicians diagnose and treat complex heart and vascular conditions, improve patient outcomes, and support more efficient care delivery across clinical settings. The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).

2 days ago

Vice President, Regulatory Affairs Rhythm Pharmaceuticals Inc

Boston, MA

$260,000–$360,000 / year

This leader will oversee a geographically diverse team responsible for execution of international regulatory affairs, regulatory operations, regulatory business operations, labeling, and CMC regulatory, while partnering closely with global regulatory strategy and cross-functional teams. Proven operational leadership with urgency and discipline, including experience leading high-performing teams, team leaders, and subject matter experts through growth, change, and increasing organizational complexity.

30+ days ago

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Regulatory Manager Jobs in Massachusetts

Sr. Manager Regulatory Affairs CMC Alnylam Pharmaceuticals Inc

Senior Manager, Regulatory Affairs Kymera Therapeutics

Senior Manager Regulatory Affairs Chemistry Manufacturing and Controls CMC AbbVie Inc

Manager, Regulatory Affairs Monte Rosa Therapeutics, Inc

Manager, Regulatory Affairs Deciphera Pharmaceuticals Inc

Senior Manager, Regulatory Affairs Getinge AB

Manager, Regulatory Affairs Advertising & Promotion (Work from Home) Parexel

Senior Manager, Regulatory Affairs Kymera Therapeutics Inc

Manager, Regulatory Affairs Monte Rosa Therapeutics Inc

Senior Manager, Regulatory Affairs, Operations Xenon Pharmaceuticals

Assistant Casino Regulatory Manager, MGM Springfield Commonwealth of Massachusetts

Manager Regulatory Affairs-Chemistry Manufacturing & Controls CMC AbbVie Inc

Regulatory Product Manager Acushnet Holdings Corp

Senior manager global regulatory affairs Katalyst Healthcares & Life Sciences

Manager, Regulatory Affairs Relay Therapeutics Inc

Senior Manager, Global Regulatory Affairs CMC Takeda Pharmaceutical Co Ltd

Manager, Regulatory Affairs Relay Therapeutics

Regulatory Product Manager Acushnet Company

Manager of Regulatory Compliance Signature Healthcare

Senior Manager, Regional Regulatory Lead - North America, Seqirus Vaccines CSL Behring LLC

Sr. Manager, Technical Regulatory Compliance Johnson & Johnson

Regulatory Affairs Operations Manager Third Rock Ventures LLC

Sr. Manager/Associate Director, Regulatory Affairs Oruka Therapeutics

Senior Manager, Regulatory Lead Takeda Pharmaceutical Co Ltd

Sr. Manager/Associate Director, Regulatory Affairs Oruka Therapeutics Inc

Regulatory Compliance Manager PGI Foods

Digital Assets Regulatory Management Manager Deloitte Touche Tohmatsu Ltd

Senior CMC Regulatory Strategy Manager GSK plc

Manager, Regional Regulatory Lead - LCM CSL Plasma

Senior Program Manager, Regulatory Delivery ESMP National Grid Plc

Senior Vice President, Regulatory Administration/Filings Manager The Bank of New York Mellon Corp

System Quality & Regulatory Programs Manager UMass Memorial Health

Sr Manager, Regulatory Compliance Staples Inc

Regulatory Reporting Manager Deloitte Touche Tohmatsu Ltd

System Quality /Regulatory Program/ Process Manager UMass Memorial Health Care Inc

Manager, Global Regulatory Operations Disc Medicine Inc

Applied AI Manager Regulatory Covington & Burling LLP

Lead Environmental Regulatory Specialist/Project Manager Foth & Van Dyke LLC

Litigation Marketing Senior Manager - Regulatory Cooley LLP

1940 Act Regulatory Administration Manager U.S. Bancorp

Manger, Transplant Quality & Regulatory Compliance Lahey Hospital and Medical Center

Manger, Transplant Quality & Regulatory Compliance Beth Israel Lahey Health

Regulatory Intelligence Manager KARL STORZ Endovision Inc

Director, Regulatory Affairs Liaison, Vaccines & Infectious Diseases Merck & Co Inc

Director, Business Development Regulatory Affairs Olympus Corp

Sr. Specialist, Regulatory Affairs LeMaitre

Senior Director, Regulatory Affairs Skyhawk Therapeutics Inc

Director, Regulatory Affairs – Global Regulatory Strategy Monte Rosa Therapeutics, Inc

Senior Regulatory Affairs Specialist Medtronic Plc

Vice President, Regulatory Affairs Rhythm Pharmaceuticals Inc

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