Regulatory Affair Lead jobs in Massachusetts

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SENIOR REGULATORY AFFAIRS PROGRAM LEAD

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CompanyJohnson & Johnson
AddressRaynham, MA
CategoryInformation Technology
Date Posted 4 weeks ago See detail

Senior Regulatory Affairs Program Lead

Johnson & Johnson

Raynham, MA

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Regulatory Affairs Specialist - Labeling

Nesco Resource

Andover, MA

Up to $38.46 •

Maintains current knowledge of the development and changes to applicable laws, regulations and industry standards for global markets, providing guidance in interpreting regulations and agency guidelines.. Initiates, reviews and a...

Director - Global Regulatory Lead

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...