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Regulatory Affairs Director jobs in Massachusetts

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MANAGER, GLOBAL REGULATORY AFFAIRS CMC

I further attest that all information I submit in my employment application is true to the best of my knowledge.Takeda Development Center Americas, Inc. is seeking a Manager, Global Regulatory Affairs CMC in Cambridge, MA with the...

CompanyBiospace
AddressBoston, MA
CategoryInformation Technology
Job typeFull time
Date Posted yesterday See detail

Manager, Global Regulatory Affairs CMC

Biospace

Boston, MA

I further attest that all information I submit in my employment application is true to the best of my knowledge.Takeda Development Center Americas, Inc. is seeking a Manager, Global Regulatory Affairs CMC in Cambridge, MA with the...

yesterday seen See more...

Director - Global Regulatory Lead New

Biospace

Lexington, MA

Serve as a member of the Global Project Team (GPT) utilizing precedent and experience to develop innovative and flexible approaches to achieve development goals, advise on development strategies, and deliver on associated regulato...

an hour ago seen See more...

Director of Transmission Policy & Regulatory Affairs - East Coast

Equinor

Boston, MA

Lead Transmission Policy and regulatory efforts related to large-scale renewable and energy storage development across eastern region. Work in coordination with East CoastPolicy & Regulatory Lead to integrate actionable transmiss...

a month ago seen See more...

Director, Regulatory Affairs

Biospace

Waltham, MA

Interact with other departments to develop regulatory strategy and submission plans for quality and timely filings. As a member of program teams, provide global regulatory guidance regarding requirements for clinical development a...

a month ago seen See more...

Director, Regulatory Affairs U.S. Advertising and Promotion (USAP)

Alnylam Pharmaceuticals

Cambridge, MA

The Director for USAP will report to the Senior Director of U.S. Advertising and Promotion.Summary of Key Responsibilities Collaborate with colleagues in Commercial, Medical Affairs, Legal, Compliance and other expertise areas in...

2 months ago seen See more...

Director, Regulatory & Quality Affairs

Mdc Associates

Beverly, MA

Direct and coordinate MDCs Regulatory Affairs activities. Collaborate with other MDC departments including Clinical Affairs and Quality Systems to ensure continuity of service across client projects. Support business development...

4 weeks ago seen See more...

Director, Global Regulatory Lead (Oncology)

Biospace

Boston, MA

Interfaces with the LRST and AST to lead and support cross-functional company objectives.Leads the GRPT to development of creative global strategies in line with applicable regulations to achieve business objectives for developmen...

7 days ago seen See more...

Associate Director, US Medical Advertising and Promotions Regulatory (GI)

Biospace

Lexington, MA

Mentor and develop staff. Supervise, trains and provides technical and regulatory guidance to staff. You will serve as the chair of promotional review meetings, and assist commercial with the planning and prioritization of propose...

7 days ago seen See more...

Senior Director, Regulatory Information Management

Biospace

Waltham, MA

Develop and implement the strategy for Regulatory Information Management including processes and optimization of systems. Develop and implement the strategy for operationalizing simultaneous marketing application filings in multip...

a week ago seen See more...

Manager - Regulatory Affairs

Biospace

Lexington, MA

Compile, submit and maintain applications (IND, CTAs, NDAs etc.) to regulatory agencies in support of investigational and marketed products, including compiling and submitting responses to agency queries. Create and maintain produ...

2 weeks ago seen See more...

Associate Director, Congress Strategy Lead, Global Medical Affairs Oncology

Biospace

Boston, MA

Co-develop Oncology external engagement strategy and lead the development of the cross-portfolio Congress Strategy and narrative for global congresses.. Liaise cross-functionally within Global Medical Affairs Oncology, and with OT...

2 weeks ago seen See more...

Director of Special Projects-Academic Affairs

Bunker Hill Community College

Boston, MA

Participate in grant proposal meetings for new initiatives. Conduct research for proposals, including outreach to faculty and staff. Support completion of grant proposals in collaboration with Grants Office and BHCC Foundation. Co...

2 weeks ago seen See more...

Senior Regulatory Affairs Program Lead

Johnson & Johnson

Raynham, MA

...

3 weeks ago seen See more...

Manager, Regulatory Affairs CMC

Biospace

Boston, MA

I further attest that all information I submit in my employment application is true to the best of my knowledge.Takeda Development Center Americas, Inc. is seeking a Manager, Global Regulatory Affairs CMC in Cambridge, MA with the...

3 weeks ago seen See more...

Senior Director, Corporate Legal Affairs (Hybrid)

A Precision Therapy Company

Cambridge, MA

Handle SEC and Nasdaq reporting and compliance, including drafting 10-K, 10-Q, 8-K, S-3, S-8, annual meeting, and Section 16 filings. Partner with cross-functional teams to review press releases, scripts, medical meeting materials...

2 weeks ago seen See more...

Associate Director, Global Regulatory Labeling

Biospace

Cambridge, MA

Develop and maintain current knowledge of labeling regulations and industry standards for labeling and communicate requirements to stakeholders as needed.. Direct the labeling control process for tracking, implementation, and regu...

2 weeks ago seen See more...

DIRECTOR OF GRADUATE STUDENT SUPPORT, Associate Provost for Graduate Affairs

Boston University

BOSTON, MA

The Director will be an experienced student affairs leader well-versed in current trends of higher education, able to identify and respond to emerging needs in graduate education through developing programs, collaborative projects...

3 weeks ago seen See more...

SVP, Global Regulatory Affairs

Biospace

Waltham, MA

Ensure the development, preparation, and implementation of global strategic regulatory plan for all programs and product pipeline designed to maximize successful and expedient global product registrations. Responsible for managing...

4 weeks ago seen See more...

Regulatory Affairs Specialist

Teleflex

Chelmsford, MA

$90,000 - $110,000 a year

Obtain timely market authorizations for Interventional products. Ensure regulatory requirements are met for quality systems, labeling, and promotional materials. Assess the impact of proposed regulations and guidance documents on...

a month ago seen See more...

Regulatory Affairs Manager

Pramand Llc

Bedford, MA

$97.2K - $123K a year

Regulatory Strategy Formulate and execute regulatory strategies to assure timely and successful product approvals. Provide regulatory guidance to crossfunctional teams to support product development and commercialization. Regula...

a month ago seen See more...

Sr. Regulatory Affairs Manager

Mass General Brigham Health Plan

Somerville, MA

$129K - $163K a year

Lead the management of a portfolio of federal regulations, inclusive of policy development, external advocacy work, and gathering internal feedback in support of the advocacy work. Serve as the regulatory subject matter expert on...

a month ago seen See more...

Manager, Regulatory Affairs CMC

Takeda Pharmaceutical

Boston, MA

$133,000 - $209,000 a year

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, c...

a month ago seen See more...

Regulatory Affairs Sr Manager (Medical Device)

Connexion Systems & Engineering, Inc.

Westford, MA

Responsible for the oversight of Regulatory Affairs as directed. Plans, analyzes, and prepares regulatory submissions for FDA and may support other international agencies as necessary. Manages the collection and coordination of in...

a month ago seen See more...

VP of Quality and Regulatory Affairs

Oxenham Group Llc

Woburn, MA

Develop and implement plans to ensure product product and market approval in various regions. Prepare and submit all regulatory filings. Responsible for regulatory compliance ensuring local and international regulations and standa...

a month ago seen See more...

Remote - Sr. Regulatory Affairs Associate - Pharmaceuticals

Fresenius Medical Care

Waltham, MA

Provides regulatory assessment and support. Evaluates and assesses regulatory impact of proposed product changes. Contributes to strategic planning as regulatory representative on interdepartmental pharmaceuticals development team...

a month ago seen See more...

Remote - Regulatory Affairs Associate II Pharma

Fresenius Medical Care

Waltham, MA

$87.1K - $110K a year

Provides regulatory assessment and support. Evaluates and assesses regulatory impact of proposed product changes. Contributes to strategic planning as regulatory representative on interdepartmental pharmaceuticals development team...

a month ago seen See more...

Manager Quality Assurance and Regulatory Affairs, Laboratory Service

Akoya Biosciences

Marlborough, MA

$130,000 - $150,000 a year

Directly manage QA Lab Support personnel. Lead the Quality Assurance processes for Clinical Research Services (CRS). Help implement and maintain quality/regulatory aspects of CLIA, GLP and ICH-GCP. Ensure CRS team is up to date on...

2 months ago seen See more...

Director, Global Medical Affairs - Oncology

Biospace

Cambridge, MA

Provide subject matter area expertise and leadership for cross-functional internal workstreams including Pharmacovigilance, Biostatistics, Clinical Operations, Regulatory Affairs and Brand teams.. Develop and foster relationships...

4 weeks ago seen See more...

Associate Director, Regulatory Operations

Biospace

Waltham, MA

Serve as an administrator for RIM and provide direct support to functional disciplines and program teams responsible for developing submission contents. Manage day-to-day submission activities both internally and in collaboration...

a month ago seen See more...

Director, Medical Affairs

Verve Therapeutics, Inc.

Boston, MA

$200K - $253K a year

Partner with the Senior Director, Medical Affairs, and Chief Medical Officer to support the establishment of the Medical Affairs function at Verve. Develop and execute scientific communication plans for Verve clinical and preclini...

a month ago seen See more...

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