1,154 Results for

Regulatory Affairs Jobs in Winthrop, MA

Jobs

Document Control/Regulatory Compliance Coordinator - M PLS Staffing Solutions, Inc

Beverly, MA

$60,000–$65,000 / year
Full time

Responsible for creation, organization, control, and maintenance of various core processes documentation (Engineering, Quality, and other Operations) in accordance with the company Quality Management System (QMS) procedures and policies. Regulatory Compliance will support the organization's Regulatory Affairs and Quality Assurance functions in multiple areas including documentation, compliance, audits and regulatory submissions.

7 days ago

Associate Director, Clinical Assay Strategy, Flu CSL Seqirus

Waltham, MA

$179,000–$212,000

This role is intended for a recognized subject matter expert who understands the scientific, operational, and regulatory evolution of influenza immunogenicity assessment, including HAI, microneutralization (MN), ELLA, and multiplex platforms, and can strategically navigate assay modernization while maintaining regulatory alignment. Headquartered in Melbourne, Australia, with major manufacturing hubs in Holly Springs, NC, and Liverpool, UK, the company operates the world’s largest cell-based vaccine facility and serves as a primary partner to governments for global pandemic preparedness.

14 days ago

Senior Director, Immunology and Translation CSL Behring

Waltham, MA

$302,000–$350,000

You will bring end-to-end experience from early ideation through first-in-disease and will partner closely with cross-functional teams including discovery research, translational medicine, clinical development, and business development to shape and advance CSL Behring's immunology pipeline. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

14 days ago

Sr. Network Architect ECLARO

Boston, MA

Strong hands-on knowledge of LAN/WAN protocols and technologies including Carrier Ethernet, T1, DS3, optical, DWDM, NTP, Spanning Tree, VLAN's, 802.1q, VFR, LFA, SMTP, SNMP v1-v3, OSPF, BGP, MPLS, VPLS, Ethernet, TCP/IP, SSL, SSH, SIP, H.323, QoS, Multicast, Anycast, 802.1x, Radius, NAC, DHCP, DNS, F5 Wide-IP, VRRP, HSRP, GLBP, PBR, VPC, LACP, SGT, SGACL, SXP, VxLAN, OTP, LISP, SPAN, WCCP, PfR, IPSLA, iWAN, VPN, IPSec, Wi-Fi 6, 6E, 7. Proven experience and success with planning, installing and managing networks including LAN, MAN, WAN, Optical Networking, DWDM, Wi-Fi, Silverpeak SDWAN or Riverbed WAN Optimizers, F5 Load Balancers, F5 GTM Global Traffic Manager, Cisco Catalyst Center, and security (firewalls, VPN, DMZ, IDS/IPS, WebProxy, content filter, FireEye, NAC and Cisco TrustSec) infrastructure.

7 days ago

Physician - Staff Radiologist Department of Veterans Affairs

Jamaica Plain, MA

3) Non-US residency training programs followed by a minimum of three years of verified independent practice in the United States (performing under a full and unrestricted license) performing duties related to the position they are applying for (United States fellowships would be creditable towards this requirement), which the local Medical Staff Executive Committee deems to have provided the applicant with appropriate professional training and believes has exposed the Physician to an appropriate range of patient care experiences. The nuclear medicine service skills desired include, but are not limited to, interpretation of general nuclear medicine studies, nuclear medicine cardiac studies, and PET/CT studies in addition to limited non-imaging uses of unsealed sources such as thyroid probe uptake measurements.

1 day 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

Regulatory Affairs Manager Dentsply Sirona

Boston, MA

This role works closely with business partners for registrations in their respective countries to ensure compliance globally and acts as an internal champion for initiatives aimed at improving business systems and compliance. • Manages day-to-day activities for less senior Regulatory Affairs professionals, including but not limited to mentoring, coaching, performance reviews, developmental plans, and succession planning.

12 days ago

Vice President, Regulatory Affairs Rhythm Pharmaceuticals

Boston, Massachusetts

30+ 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.

16 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.

23 days ago

Regulatory Affairs Program Manager Intellectt INC

Raynham, MA

Industry: Medical Devices We're looking for an experienced Regulatory Affairs Program Manager with: 10+ years of Medical Device Regulatory Affairs experience. FDA 510(k), PMA & Global Regulatory Submissions knowledge.

9 days ago

Associate Director Regulatory Affairs Viridian Therapeutics Inc

Waltham, MA

Reporting to the Senior Director, Regulatory Affairs, the Associate Director, Regulatory Affairs will represent Regulatory Affairs on assigned cross-functional teams and lead day-to-day regulatory activities for product development and approval in alignment with the corporate strategy for Viridian's Thyroid Eye Disease (TED) and TSHR portfolio. Communicate with internal and external stakeholders, including members of the leadership teams, to ensure cross-functional alignment, work with Regulatory CMC and Regulatory Operations teams to establish and meet timelines for regulatory submissions.

30+ 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

Senior Director Regulatory Affairs Liaison- General Medicine Merck & Co Inc

Boston, MA

$190,800–$300,300 / year

Required Skills: Corporate Commercial, Cross-Cultural Awareness, Drug Development, Exercises Judgment, Global Health, Global Market, Healthcare Innovation, Interpersonal Relationships, In Vitro Diagnostics (IVD), Multiple Therapeutic Areas, Oral Communications, Orphan Drugs, Pharmaceutical Regulatory Affairs, Process Improvements, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Communications, Regulatory Compliance, Regulatory Issues, Regulatory Management, Regulatory Strategy Development, Written Communication. As the Global Regulatory Lead (GRL), the Senior Principal Scientist functions as the regulatory single, accountable, global point of contact on the project team and interacts with the global regulatory agencies and/or subsidiaries with regard to global regulatory strategy/registration requirements for one or more company investigational and marketed drugs/biologics in early- and/or late-stage development.

30+ days ago

Director, Regulatory Affairs – Clinical Strategy 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.

30+ days ago

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

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.

17 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.

13 days ago

Director, Regulatory Affairs - Clinical Strategy Azurity Pharmaceuticals Inc

Woburn, MA

Brief Team/Department Description: 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. Principle Responsibilities: • 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.

30+ days ago

Sr. Specialist, Regulatory Affairs LeMaitre Vascular Inc

Burlington, MA

$110,000–$150,000 / year

Provide support to currently marketed products including: reviewing of engineering change orders, labeling, promotional material, product changes and documentation for changes requiring regulatory approval. The Regulatory Affairs Manager will report to the VP of Regulatory Affairs and have the following primary responsibilities: Responsible for preparation of regulatory submissions, including FDA 510(K), CE Technical Documentations, Canadian Device Applications, etc.

9 days ago

Senior Manager, Regulatory Affairs NAM Straumann Holding AG

This role leads the planning, preparation, and submission of regulatory filings (e.g., Pre-Submissions, 510(k)s, PMAs, PMA Annual Reports, IDEs, and License Applications) and serves as a key regulatory partner to cross-functional teams. This role collaborates closely with global regulatory counterparts within the Straumann Group (e.g., Medentika, Neodent, Anthogyr, Dental Wings, etc.) and manages/develops regulatory staff and/or leads complex regulatory projects.

30+ days ago

Senior Director, Regulatory Affairs Strategy - Cell and Gene Therapy AstraZeneca Plc

Boston, MA

$218,058–$327,087 / year

Accountabilities: Global Regulatory Leadership: Own the end-to-end global regulatory strategy for a high-complexity cell and gene therapy program, from current stage through BLA submission, ensuring an efficient route to approval with competitive labeling aligned to product attributes and patient, market and business needs. Cross-Functional Product Leadership: Represent Regulatory Affairs on Global Product Teams, shaping development and commercialization plans, contributing to governance presentations and aligning regulatory objectives with clinical, CMC, safety and commercial strategies.

27 days ago

Senior Director, Regulatory Affairs Bicara Therapeutics

Boston, Massachusetts

FICERA specifically addresses a key challenge in solid tumor treatment by enabling immune cell penetration into tumors, reducing fibrosis and immunosuppression while reversing TGF--driven resistance mechanisms - ultimately designed to drive the deep, durable responses that may translate into better outcomes and survival for patients. Founded in 2020, we've built a global team of over 100 employees headquartered in Boston, with a clear focus on advancing our lead asset, ficerafusp alfa, or FICERA - a potentially first-in-class bifunctional EGFR-directed antibody combined with a TGF- ligand trap.

30+ days ago

Regulatory Affairs Manager - Labeling Cardinal Health Inc

Mansfield, MA

Remote

$105,100–$150,100 / year

Symbol and Mark Management: Ensure the correct application of environmental symbols and marks, including those for the WEEE Directive, battery directives (e.g., crossed-out wheeled bin), recycling (e.g., "Green Dot," Mobius loop), and packaging material identification. Risk Management: Ability to apply risk management principles (ISO 14971) to the labeling process, identifying and mitigating risks associated with labeling errors, such as product recalls, shipping holds, or regulatory enforcement actions.

16 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.

15 days ago

Executive Director, Regulatory Affairs Merck & Co Inc

$255,800–$402,700 / year

10% Travel Required Skills: Antibody Drug Conjugates (ADC), Antibody Drug Conjugates (ADC), Biopharmaceuticals, Biopharmaceutics, Chemistry, Collaborative Development, Confidentiality, Cross-Cultural Awareness, Decision Making, Electronic Common Technical Document (eCTD), Executive Management, Mentoring Staff, People Leadership, Pharmaceutical Sciences, Professional Networking, Project Management, Regulatory Affairs Management, Regulatory CMC, Regulatory Compliance Audits, Regulatory Development, Regulatory Monitoring, Regulatory Reporting, Regulatory Risk, Regulatory Submissions, Risk Analysis {+ 2 more} Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Accountable for ensuring successful development and implementation of the global CMC regulatory strategy and for global registration and post approval strategy for new products to meet our company's business needs Leads the team responsible regulatory CMC deliverables including submissions supporting clinical studies through initial market applications and post-approval to ensure global commercial supply.

30+ days ago

Director, Global Regulatory Affairs Process Excellence and Transformation Vertex Pharmaceuticals Inc

Boston, MA

$196,800–$295,200 / year

As a key member of the GRA Process Optimization Network (GPON), this role consults with cross-team representatives to diagnose operational challenges and deliver scalable, sustainable solutions. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations.

30+ days ago

Sr Regulatory Affairs Spec Medtronic Plc

Boston, MA

This role will partner closely with Geography Regulatory Affairs to support international submissions, government queries, registration documentation, product approval and clearance activities, product demand and release planning, and post-market regulatory compliance to help ensure continued product availability worldwide. 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).

30+ days ago

Associate Director Regulatory Affairs Alnylam Pharmaceuticals Inc

Cambridge, MA

$170,900–$231,300 / year

Additional responsibilities include involvement in the writing and oversight of regulatory submissions, coordinating all aspects of paper and electronic regulatory submissions, proactively keeping updated on US regulatory requirements, and interpreting regulatory intelligence for the internal teams. Serve as member of/or lead the Global Regulatory Team, may serve as Regulatory representative in multidisciplinary product subteams or core team for assigned programs and participate as an active team member.

22 days ago

Strategy Lead, CMC Mature, Regulatory Affairs GSK plc

Cambridge, MA

$113,850–$189,750 / 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. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment.

24 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

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

Head of Regulatory Affairs Pulpdent Corp

Pulpdent is third-generation family-owned business that is widely respected for its innovative products and authentic company culture, which promotes work-life balance, employee retention, and product excellence. The Head of Regulatory Affairs will lead and evolve Pulpdent's global regulatory strategy across the full product lifecycle-from R&D and commercialization to quality assurance and post-market surveillance.

22 days ago

Senior Manager, Regulatory Affairs Getinge AB

Nashua, NH

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.

13 days ago

Director, Regulatory Affairs Strategy - Cell Therapy AstraZeneca Plc

Boston, MA

$186,232–$279,349 / year

Partnering with senior leaders and global teams, you will lead strategy across key milestones-from expedited designations and Health Authority interactions through major submissions and post-approval maintenance-helping the business deliver transformative therapies at pace and with rigor. In this Director role, you will shape the regulatory path for programs that span oncology, immune-mediated and rare diseases-translating breakthrough science into timely approvals and competitive labeling that make a tangible difference to patients and markets.

5 days ago

Executive Director, Global Regulatory Affairs CMC Early Development Takeda Pharmaceutical Co Ltd

Boston, MA

$238,000–$374,000 / year

Accountable for ensuring global CMC content quality and compliance for early development submissions and lifecycle changes through Phase 2 (e.g., IND/CTA modules, IMPD quality sections, amendments, investigator's brochure CMC, and responses to health authority questions), partnering with regional leads and technical functions to ensure consistent, inspection-ready documentation. Represents Global Regulatory Affairs CMC in senior-level governance and in interactions with global health authorities, including FDA, EMA, MHRA, PMDA, and other agencies as applicable, to enable efficient pathways for early development CMC strategies and submissions (e.g., pre-IND/IND/CTA, amendments, Type B/C meetings, scientific advice).

20 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

Manager, Regulatory Affairs Monte Rosa Therapeutics Inc

Boston, MA

30+ days ago

Senior Manager, Regulatory Affairs Kymera Therapeutics Inc

Watertown, MA

$145,000–$215,000 / year

21 days ago

Regulatory Affairs Strategy Director AstraZeneca Plc

Boston, MA

$186,232.80–$279,349.20 / year

Competitive salary and benefits package on offer: Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. The more experienced you are, the more accountability you will have for strategic leadership including responsibility for development and implementation of the global regulatory strategy for a product/group of products of increasing complexity.

26 days ago

Vice President, Head of Regulatory Affairs Zevra Therapeutics

Boston, Massachusetts

This leader owns the global regulatory strategy and execution across the portfolio consisting of commercial products and development assets. The VP of RA demonstrates exceptional leadership skills and a passion for fostering professional growth within their team as well as improving the internal processes in the department.

30+ 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

Chief of Staff, Senior Director Global Regulatory Affairs AstraZeneca Plc

Boston, MA

$218,058.40–$327,087 / year

Organizational Effectiveness and Change: Support organization design, capability building, and talent initiatives; lead change programs and improvements in ways of working that increase clarity, speed, and accountability across the regulatory organization. Cross-Functional and Enterprise Coordination: Partner across R&D, Commercial, Safety, Medical, Legal, Finance, and Procurement to align competing priorities; coordinate across programs, therapy areas, and regions to resolve complex issues that impact filing readiness and approvals.

5 days ago

Vice President, Global Head of Regulatory Affairs Azurity Pharmaceuticals Inc

Woburn, MA

As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline. The company's patient-centric products span the cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, and have benefited millions of patients.

27 days ago

Vice President, Global Head of Regulatory Affairs Azurity Pharmaceuticals - US

Woburn, MA

21 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

Executive Director, Regulatory Affairs Dyne Therapeutics Inc

Waltham, MA

$250,000–$310,000 / year

Role Summary: The Executive Director, Regulatory Affairs serves as a visionary leader who shapes long-term program regulatory strategy, collaborates on regulatory functional strategy, and drives organizational impact across Dyne''s regulatory operations. This position requires a leader who contributes to department-wide strategy, develops corporate policies and processes that influence the organization''s direction, and ensures alignment with the mission of delivering meaningful outcomes for patients.

30+ 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

Associate Director Regulatory Affairs – Vascular (on-site) Abbott

Westford, Massachusetts

Maintains expert working knowledge of laws, regulations and enforcement decisions related to Quality Assurance (QA), manufacturing and Research & Development (R&D) issues that may impact company operations and decision making; communicates such knowledge to all internal stakeholders. As a manager, the function of an Associate Director, Regulatory Affairs is to combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation.

30+ 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

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Regulatory Affairs Jobs in Winthrop, MA

Document Control/Regulatory Compliance Coordinator - M PLS Staffing Solutions, Inc

Associate Director, Clinical Assay Strategy, Flu CSL Seqirus

Senior Director, Immunology and Translation CSL Behring

Sr. Network Architect ECLARO

Physician - Staff Radiologist Department of Veterans Affairs

Vice President, Regulatory Affairs Rhythm Pharmaceuticals Inc

Regulatory Affairs Manager Dentsply Sirona

Vice President, Regulatory Affairs Rhythm Pharmaceuticals

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

Sr. Specialist, Regulatory Affairs LeMaitre

Regulatory Affairs Program Manager Intellectt INC

Associate Director Regulatory Affairs Viridian Therapeutics Inc

Manager, Regulatory Affairs Monte Rosa Therapeutics, Inc

Senior Director Regulatory Affairs Liaison- General Medicine Merck & Co Inc

Director, Regulatory Affairs – Clinical Strategy Azurity Pharmaceuticals - US

Sr. Manager Regulatory Affairs CMC Alnylam Pharmaceuticals Inc

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

Senior Manager, Regulatory Affairs Kymera Therapeutics

Director, Regulatory Affairs - Clinical Strategy Azurity Pharmaceuticals Inc

Sr. Specialist, Regulatory Affairs LeMaitre Vascular Inc

Senior Manager, Regulatory Affairs NAM Straumann Holding AG

Senior Director, Regulatory Affairs Strategy - Cell and Gene Therapy AstraZeneca Plc

Senior Director, Regulatory Affairs Bicara Therapeutics

Regulatory Affairs Manager - Labeling Cardinal Health Inc

Senior Manager Regulatory Affairs Chemistry Manufacturing and Controls CMC AbbVie Inc

Executive Director, Regulatory Affairs Merck & Co Inc

Director, Global Regulatory Affairs Process Excellence and Transformation Vertex Pharmaceuticals Inc

Sr Regulatory Affairs Spec Medtronic Plc

Associate Director Regulatory Affairs Alnylam Pharmaceuticals Inc

Strategy Lead, CMC Mature, Regulatory Affairs GSK plc

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

Manager, Regulatory Affairs Deciphera Pharmaceuticals Inc

Head of Regulatory Affairs Pulpdent Corp

Senior Manager, Regulatory Affairs Getinge AB

Director, Regulatory Affairs Strategy - Cell Therapy AstraZeneca Plc

Executive Director, Global Regulatory Affairs CMC Early Development Takeda Pharmaceutical Co Ltd

Sr. Manager/Associate Director, Regulatory Affairs Oruka Therapeutics

Manager, Regulatory Affairs Monte Rosa Therapeutics Inc

Senior Manager, Regulatory Affairs Kymera Therapeutics Inc

Regulatory Affairs Strategy Director AstraZeneca Plc

Vice President, Head of Regulatory Affairs Zevra Therapeutics

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

Chief of Staff, Senior Director Global Regulatory Affairs AstraZeneca Plc

Vice President, Global Head of Regulatory Affairs Azurity Pharmaceuticals Inc

Vice President, Global Head of Regulatory Affairs Azurity Pharmaceuticals - US

Senior Manager, Regulatory Affairs, Operations Xenon Pharmaceuticals

Executive Director, Regulatory Affairs Dyne Therapeutics Inc

Senior manager global regulatory affairs Katalyst Healthcares & Life Sciences

Associate Director Regulatory Affairs – Vascular (on-site) Abbott

Senior Manager, Global Regulatory Affairs CMC Takeda Pharmaceutical Co Ltd

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