Senior Regulatory Affair jobs in Massachusetts

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SENIOR REGULATORY AFFAIRS PROGRAM LEAD

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CompanyJohnson & Johnson
AddressRaynham, MA
CategoryInformation Technology
Date Posted 3 weeks ago See detail

Senior Regulatory Affairs Program Lead

Johnson & Johnson

Raynham, MA

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Regulatory Affairs Specialist - Labeling New

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...

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...

Seasonal Senior Shorebird Specialist, Marine & Environmental Affairs

Town Of Barnstable, Massachusetts

Centerville, MA

Seasonal (SEAS) Position Technical work assessing and monitoring shorebird nesting activity at Sandy Neck and associated sites. Minimum Qualifications: High School graduation with college level coursework in biology, wildlife mana...

Senior Manager, US Medical Advertising and Promotions Regulatory (GI)

Biospace

Lexington, MA

I further attest that all information I submit in my employment application is true to the best of my knowledge.About the role:Join Takeda as a Senior Manager, US Medical Ad/Promo Regulatory Review, GI where you will be an interna...

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...

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...

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...

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...

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 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...

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...

Financial Regulatory Reporting Senior Analyst II

Federal Reserve Bank Of Boston

Boston, MA

$87.3K - $111K a year

Provide financial and business analyses that highlight data issues, and present contextual information that supports the reasonableness of the reported data. Recognize, identify, and document data anomalies, trends, and cause-effe...

Financial and Regulatory Reporting - TSR Operations, Senior Associate

State Street

Quincy, MA

Not disclosed

Manage the Regulatory Reporting production process, calendar and relationship for various clients and ensure that all production schedules (including those with the off-shore teams) are completed in a timely manner so that all tea...

Senior Manager, Regulatory Strategy

Praxis Precision Medicines

Charlestown, MA

$162,000 - $176,000 a year

Primary regulatory representative on multi-disciplinary project teams and provide strategic regulatory guidance on development plans Prepare regulatory development plans for assigned projects and establish/manage regulatory timeli...