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2,349

Regulatory Affairs Manager Jobs Near Lexington, MA

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Salary Range

$40K

$250K

Average Salary: $94,524
Regulatory Affairs Manager

Identifies potential regulatory approval risks based on changes in regulations, standards, country specific issues, or other unique characteristics of projects...

Posted 6d ago

  •   8 - 10 years exp.  •  Pharmaceuticals & Biotech

Manager, Regulatory Affairs

Monitor impact of changing evolving global regulations on submissions, practices and procedures and communicate to internal stakeholders.

Posted 6d ago

  •   8 - 10 years exp.  •  Business Services

Senior Manager, Regulatory Affairs

Responsible for assembling required documentation for all classes of medical devices; communicate /and give guidance to other departments regarding strategy, format and timeline expectation...

Posted 2d ago

  •   11 - 15 years exp.  •  Healthcare

Regulatory Affairs Specialist

Acts as a regulatory representative on product development teams, communicates regulatory requirements and impact of regulations to the development team...

Posted 2d ago

  •   8 - 10 years exp.  •  Manufacturing & Automotive

Director, Regulatory Affairs

Preferred candidates will have experience working as a lead in Regulatory.

Posted Yesterday

  •   11 - 15 years exp.  •  Pharmaceuticals & Biotech

Manager, Regulatory Affairs

Work with manager/regulatory lead and program team in planning and preparing for health authority meetings.

Posted 2w ago

  •   Less than 5 years exp.  •  Pharmaceuticals & Biotech

Senior Regulatory Affairs Specialist

The Senior Regulatory Affairs Specialist will plan a key role as the executor of the corporate regulatory strategy. This individual will provide input into regulatory programs and ensure that the org...

Posted 4d ago

  •   5 - 7 years exp.  •  Healthcare

Director, Regulatory Affairs

Implement the overall clinical and nonclinical global regulatory strategy across the product lifecycle towards initial approval, launch, and label expansions...

Posted 1w ago

  •   11 - 15 years exp.  •  Pharmaceuticals & Biotech

Associate Director, Regulatory Affairs

Provides Regulatory project management leadership to the preparation of INDs, CTAs, BLAs, amendments and supplements, annual reports, DSURs, and supplements for FDA and other regulatory health authori...

Posted 6d ago

  •   8 - 10 years exp.  •  Pharmaceuticals & Biotech

Associate Director Regulatory Affairs

Has recognized regulatory expertise and extensive knowledge of regulatory requirements and regulations with ability to strategically interpret and communicate requirements...

Posted Today

  •   5 - 7 years exp.  •  Pharmaceuticals & Biotech

Regulatory Affairs Director

As Regulatory Affairs Director, you plan, direct, or coordinate regulatory activities linked to business activities to ensure compliance with applicable regulations...

Posted 2w ago

  •   8 - 10 years exp.  •  Pharmaceuticals & Biotech

ASSOCIATE DIRECTOR, REGULATORY AFFAIRS

Collaborate with cross-functional teams to generate and refine the product development strategy.

Posted Yesterday

  •   8 - 10 years exp.  •  Pharmaceuticals & Biotech

Director, Regulatory Affairs, Regulatory

Prepare, review and coordinate documents submitted to regulatory health authorities to assure they are complete, organized, of high quality, and compliant with applicable regional regulations. Oversee...

Posted 2w ago

  •   8 - 10 years exp.  •  Pharmaceuticals & Biotech

Associate Director, Regulatory Affairs, Medical Writing

Collaborate cross-functionally with department heads, document leads and subject matter experts (SMEs) across the business (ex., Clinical Research, Medical Affairs, Clinical Operations, Pharmacovigila...

Posted Today

  •   8 - 10 years exp.  •  Pharmaceuticals & Biotech

Director/Senior Director, Regulatory Affairs

The person in this role serves as a resource to team members for the regulatory requirements, processes, and logistics to conduct global drug development for therapies from the preclinical stage...

Posted Today

  •   11 - 15 years exp.  •  Pharmaceuticals & Biotech

Executive Director, Regulatory Affairs

Develop and implement well-informed global regulatory strategies in a project team environment, with a focus on clinical and nonclinical drug development...

Posted 1w ago

  •   11 - 15 years exp.  •  Pharmaceuticals & Biotech

Senior Director, Regulatory Affairs Strategy

Develop fit for purpose regulatory strategies incorporating totality of development (clinical, nonclinical, and CMC) and driving engagements that result in high value feedback from global health autho...

Posted 6d ago

  •   11 - 15 years exp.  •  Pharmaceuticals & Biotech

Manager, Regulatory Affairs- Advertising, Promotion, and Labeling

Working with Regulatory Operations to ensure required OPDP submission of promotional materials are appropriately filed with the FDA.

Posted 1w ago

  •   5 - 7 years exp.  •  Pharmaceuticals & Biotech

Associate Director, CMC Regulatory Affairs
$100K — $150K *

Work in cross-functional matrix project teams in regulatory, chemical and pharmaceutical development and manufacturing areas.

Posted 1w ago

  •   5 - 7 years exp.  •  Pharmaceuticals & Biotech

Director, Regulatory Affairs

Contributes to the strategy for interaction with Health Authorities or business partners in the assigned area. Builds and maintains good relationships with Regulatory Authorities...

Posted 2w ago

  •   11 - 15 years exp.  •  Pharmaceuticals & Biotech

Regulatory Affairs Manager (Head of Regulatory Affairs)

Thorough understanding and demonstrated ability to apply regulatory guidelines/regulations to successful dossier preparation, submissions, and maintenance. Ability to develop innovative strategies and...

Posted 3w ago

  •   11 - 15 years exp.  •  Pharmaceuticals & Biotech

Manager, Regulatory Affairs CMC

Actively participate/lead regulatory CMC infrastructure and capability building, including developing best practices, training tools, and cross-program learning...

Posted 3w ago

  •   8 - 10 years exp.  •  Pharmaceuticals & Biotech

Director/Senior Director of Nonclinical Regulatory Affairs
$80K — $100K *

Lead the development and implementation of document strategy for the nonclinical aspects of all regulatory filings, including Module 2 summaries, pre-IND and scientific...

Posted 1w ago

  •   Pharmaceuticals & Biotech

Director/Senior Director, Regulatory Affairs CMC

Facilitating the development of reviews and comments on CMC documentation for submission to regulatory authorities including process development, process validation, analytical method development, and...

Posted 1w ago

  •   11 - 15 years exp.  •  Finance & Insurance

Director of Regulatory Affairs

Development of best practices internally to support regulatory documentation readiness, and development and maintenance of regulatory SOPs.

Posted 3w ago

  •   8 - 10 years exp.  •  Business Services

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