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605

Director of Regulatory Affairs Jobs Near Weston, MA

Director, Regulatory Affairs

Ensure effective and timely execution of regulatory filings in compliance with relevant regulatory standards and commitments.

Posted 2d ago

  •   11 - 15 years exp.  •  Pharmaceuticals & Biotech

Director, Regulatory Affairs
$200K — $250K

Independently leads the preparation, coordination or monitoring of regulatory submissions. Interacts across the organization to obtain and/or provide information/data for regulatory submissions...

Posted 2w ago

  •   11 - 15 years exp.  •  Pharmaceuticals & Biotech

Director, Regulatory Affairs CMC

Perform assessment of CMC change controls, identifying global regulatory requirements, and evaluating supporting documentation to verify acceptability and identify potential risks...

Posted 2d ago

  •   11 - 15 years exp.  •  Pharmaceuticals & Biotech

Senior Director, Regulatory Affairs

In this Regulatory Affairs role, the Senior Director will need to be resourceful, collaborative, versatile and highly knowledgeable in regulatory strategy, interactions, and submissions...

Posted 2w ago

  •   8 - 10 years exp.  •  Pharmaceuticals & Biotech

Director/Senior Director Regulatory Affairs

Provide regulatory leadership and guidance to project teams, leadership for the development of global regulatory submission documents.

Posted Yesterday

  •   11 - 15 years exp.  •  Pharmaceuticals & Biotech

Director, Regulatory Affairs

Lead regulatory interactions with health authorities including managing preparation of briefing documents.

Posted 2w ago

  •   8 - 10 years exp.  •  Pharmaceuticals & Biotech

Manager, Regulatory Affairs

Act as primary regulatory liaison with medical writers, clinical, statistics, toxicology and DMPK teams as well as external CROs to provide regulatory support for trial initiation and ongoing maintena...

Posted 1w ago

  •   Less than 5 years exp.  •  Pharmaceuticals & Biotech

Associate Director/Director, Regulatory Affairs

Builds partnerships with stakeholders from other functions to ensure that strategic business goals are met through the sharing of knowledge and expertise...

Posted 1w ago

  •   11 - 15 years exp.  •  Pharmaceuticals & Biotech

Senior Director, Regulatory Affairs
$150K — $200K

Act as a role model for professionalism and a respected ambassador for the Regulatory Business Unit, remaining effective in difficult, stressful and/or highly sensitive situations...

Posted 1w ago

  •   11 - 15 years exp.  •  Hospitals & Medical Centers

Sr. Director, Regulatory Affairs

Develops and refines and re-aligns regulatory strategy across programs in consultation with leadership. Leads regulatory interactions with global regulatory authorities, formal and informal interactio...

Posted 2w ago

  •   11 - 15 years exp.  •  Pharmaceuticals & Biotech

Vice President, Regulatory Affairs

Regulatory operations, agency interactions, and submissions, both domestically and globally, from IND to marketing applications.

Posted Yesterday

  •   11 - 15 years exp.  •  Pharmaceuticals & Biotech

Director/Senior Director, Regulatory Affairs Strategy

Provide regulatory strategic leadership for drug development projects, including but not limited, to health authority interactions, regulatory submissions and other regulatory requirements in line wit...

Posted 1w ago

  •   11 - 15 years exp.  •  Pharmaceuticals & Biotech

Director Global Regulatory Affairs - Strategy

The Director will be responsible for overseeing the development and implementation of innovative global regulatory strategies for product development and commercialization in emerging disease areas...

Posted 2w ago

  •   11 - 15 years exp.  •  Pharmaceuticals & Biotech

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

Ability to read, analyze, and interpret regulations, technical standards, guidance documents, test reports, clinical and medical terminology, technical product information, and complex documents...

Posted 5d ago

  •   5 - 7 years exp.  •  Healthcare

Senior Director, Regulatory Affairs at Relay Therapeutics

We will lean on you to lead the development and implementation of pre-clinical and clinical regulatory strategy for projects in all stages of development (pre-IND/IMPD through commercial). You will de...

Posted 5d ago

  •   11 - 15 years exp.  •  Finance & Insurance

Director, Regulatory Affairs
$150K — $200K

Acts as a Regulatory Team Leader on complex projects, which may include technical writing and/or may act as a Project Manager for a stand-alone project, with guidance from senior staff as appropriate...

Posted 2w ago

  •   8 - 10 years exp.  •  Hospitals & Medical Centers

Vice President, Regulatory Affairs

Develop US and global regulatory strategies aligned with business objectives.

Posted 1w ago

  •   15+ years exp.  •  Pharmaceuticals & Biotech

Associate Director, Regulatory Affairs

Core member of the collaboratively working with the team to represent the Business and weave strategies into global strategies as they are developed.Key contact for internal research, development and...

Posted 2w ago

  •   5 - 7 years exp.  •  Pharmaceuticals & Biotech

Director, Regulatory Affairs

The Director, Regulatory Affairs will implement the overall Regulatory strategy for the business and lead the clinical team in the execution of regulatory strategies for the portfolio of projects and...

Posted more than 4w ago

  •   11 - 15 years exp.  •  Healthcare

Director/Senior Director, Regulatory Affairs

Works cross-functionally with internal departments, including clinical, and third parties on Regulatory Affairs related issues.

Posted 3w ago

  •   11 - 15 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 3w ago

  •   11 - 15 years exp.  •  Pharmaceuticals & Biotech

Manager, Global Regulatory Affairs CMC Submissions Management

The manager establishes the document plan, negotiates timelines with authors, drives all deliverables against the timeline, compiles all submission ready documents, and delivers the final submission c...

Posted 5d ago

  •   5 - 7 years exp.  •  Pharmaceuticals & Biotech

Senior Manager/Associate Director Regulatory Affairs Compliance AdProm
$100K — $150K

This position will be responsible for the review and submission of advertising/promotional materials in compliance with FDA regulations and guidance documents. This position will also support addition...

Posted 2w ago

  •   8 - 10 years exp.  •  Pharmaceuticals & Biotech

Director, Regulatory Affairs Cmc

You will formulate and lead innovative CMC regulatory strategies for assigned development projects, represent Global Regulatory Affairs CMC on interdisciplinary project teams, and present comprehensiv...

Posted more than 4w ago

  •   8 - 10 years exp.  •  Healthcare

Director, Regulatory Affairs, CMC

Manages interactions with FDA and other regulatory authorities for assigned projects to ensure acceptance, rapid review and approval of clinical trial applications, marketing applications, amendments...

Posted 3w ago

  •   5 - 7 years exp.  •  Pharmaceuticals & Biotech