1,812

Regulatory Affairs Manager Jobs Near Lexington, MA

Salary Range

$90K

$125K

Average Salary: $111,000
Manager, Regulatory Affairs

Collaborate with regulatory and cross-functional colleagues on clinical document reviews. Prepare and review sections of regulatory submissions for IND/CTA original submissions and amendments, orphan...

Posted Today

  •   Less than 5 years exp.  •  Pharmaceuticals & Biotech

Sr. Director, Regulatory Affairs
$200K — $250K

Leads regulatory interactions with global regulatory authorities, formal and informal interactions, and represents regulatory affairs on project teams...

Posted 6d ago

  •   11 - 15 years exp.  •  Business Services

Regulatory Affairs Manager
$80K — $100K

Seeking for Regulatory Affairs Manager .

Posted 2w ago

  •   Less than 5 years exp.  •  Pharmaceuticals & Biotech

Director, Regulatory Affairs
$150K — $200K

Contributes knowledge and expertise on GRA Regulatory Science and Policy activities, as well as other related internal or external policy initiatives, in order to assure that appropriate Sanofi visibi...

Posted 1w ago

  •   5 - 7 years exp.  •  Pharmaceuticals & Biotech

(Sr) Director, Regulatory Affairs CMC

Manage completion of CMC submission documents and other assigned tasks within established timelines and with high quality – in terms of scientific content, organization, clarity, accuracy, format, con...

Posted 3d ago

  •   11 - 15 years exp.  •  Pharmaceuticals & Biotech

Senior Regulatory Affairs Specialist

Examine complaint data to determine trends that may result in corrective action, report complaint trends to management and assist in post market compliance activities, including field safety correctiv...

Posted 1w ago

  •   5 - 7 years exp.  •  Pharmaceuticals & Biotech

Director/ Senior Director, Regulatory Affairs
$200K — $250K

Review and approval of submission documents, including clinical study protocols and reports, statistical analysis plans, investigator brochures, aggregated safety reports and other documents as needed...

Posted 1w ago

  •   11 - 15 years exp.  •  Pharmaceuticals & Biotech

Senior Manager, International Regulatory Affairs

Manages global product submissions with an in-depth understanding of advanced technical/scientific principles that relate to multiple diverse and complex product lines and/or manufacturing processes...

Posted 2w ago

  •   8 - 10 years exp.  •  Healthcare

Sr. Director, Regulatory Affairs
$200K — $250K

Leads regulatory interactions with global regulatory authorities, formal and informal interactions, and represents regulatory affairs on project teams...

Posted 2w ago

  •   11 - 15 years exp.  •  Pharmaceuticals & Biotech

Head of Regulatory Affairs

Serve as regulatory leader for health authority interactions related to product development across our Depression, Neurology and Neuropsychiatry franchises, as well as promotion and advertising...

Posted 2w ago

  •   15+ years exp.  •  Pharmaceuticals & Biotech

Sr. Manager, Regulatory Affairs, CMC, Small Molecule
$80K — $100K
PTC TherapeuticsLynnfield, MA 01940 and 1 other location

Develop Module 2 and 3 documents for regulatory filings such as INDs/ IMPDs/ CTAs/ MAAs/NDAs/ global registrations and eCTD submissions, ensuring that they meet current regulatory standards and are hi...

Posted 1w ago

  •   5 - 7 years exp.  •  Pharmaceuticals & Biotech

Manager, Regulatory Affairs

The Regulatory Affairs Manager is responsible for overseeing the preparation of regulatory submissions required to market new or modified devices in both domestic and international markets including a...

Posted 3w ago

  •   8 - 10 years exp.  •  Healthcare

Senior Manager/Associate Director, Regulatory Affairs
$80K — $100K

Provide strategic guidance for and author applications related to designations for expedited programs (e.g. Fast Track Designation, Breakthrough Therapy Designation, Priority Review, Expanded Access...

Posted 1w ago

  •   5 - 7 years exp.  •  Pharmaceuticals & Biotech

VP, Regulatory Affairs

Lead global regulatory strategy and execution for all research and development programs. Expertise and experience with biologics across the full development path from pre-clinical to approvals and bey...

Posted 2w ago

  •   years exp.  Pharmaceuticals & Biotech

Director, Regulatory Affairs

The Director Northeast will support the Senior Director in developing a balanced advocacy strategy representing the best interests of all ENA business lines, including EXNA, EGPNA and ETNA...

Posted 2w ago

  •   5 - 7 years exp.  •  Energy & Utilities

Director, Global Regulatory Affairs Strategy, Oncology
$200K — $500K+

Ensure consistent roles, responsibilities, and clear accountability for oncology staff aligned with the GRA operating model. Function as the Global Regulatory Lead and US/EU Lead for 1 or more develop...

Posted 4d ago

  •   11 - 15 years exp.  •  Pharmaceuticals & Biotech

CMC Regulatory Affairs Project Manager
$80K — $100K

This position will plan and coordinate regulatory strategies necessary to support clinical development submissions, new registrations, and post approval submissions that meet global regulatory require...

Posted 2w ago

  •   5 - 7 years exp.  •  Pharmaceuticals & Biotech

Associate Director/Director, Regulatory Affairs
$150K — $200K

Develop and implement global regulatory strategy for the company’s gene editing programs,Represent the regulatory function on cross-functional product development teams. Provides innovative strategic...

Posted 2w ago

  •   11 - 15 years exp.  •  Pharmaceuticals & Biotech

Senior Director, Regulatory Affairs

Monitors regulatory developments related to Cell Therapy and advises project teams regarding the development and implementation of regulatory strategy through the clinical development processes. Ident...

Posted 2w ago

  •   11 - 15 years exp.  •  Pharmaceuticals & Biotech

Senior Director, Global Regulatory Affairs - Rare Diseases
$200K — $250K

Monitor and anticipate trends that impact both the regulatory and access environments to strengthen product development plan(s) and adopt regulatory strategies in a timely manner...

Posted 6d ago

  •   11 - 15 years exp.  •  Pharmaceuticals & Biotech

Head of Global Compliance, Global Regulatory Affairs
$200K — $250K

Building, engaging and and providing leadership to an outstanding and diverse team of compliance champions. Being responsible for the professional accomplishments and development of global regulatory...

Posted 1w ago

  •   11 - 15 years exp.  •  Pharmaceuticals & Biotech

Director/Senior Director, CMC Regulatory Affairs
$200K — $250K

Provides proactive guidance to internal groups (Quality, Manufacturing, etc) based on technical and CMC regulatory knowledge towards development of strategic and tactical plans. Identify and assess re...

Posted 1w ago

  •   11 - 15 years exp.  •  Pharmaceuticals & Biotech

Head of Regulatory Affairs
$200K — $250K

Proactively identifies third parties to supplement team expertise and additional capacity requirements and effectively manages contract/temp resources and contracting processes Supports and encourages...

Posted 3w ago

  •   11 - 15 years exp.  •  Manufacturing & Automotive

Associate Director, Global Regulatory Affairs Development Strategy

Works with management to develop and direct innovative and effective regulatory strategies in support of assigned Alexion portfolio, pipeline and therapeutic areas...

Posted 1w ago

  •   5 - 7 years exp.  •  Pharmaceuticals & Biotech

Sr. Director, Regulatory Affairs
$250K — $500K+

Develops systems and processes for regulatory operations, working with vendors as needed, Updates logs, databases and catalogues of regulatory compliance information. Working with the strategic leade...

Posted 2w ago

  •   11 - 15 years exp.  •  Pharmaceuticals & Biotech