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902

Regulatory Affairs Manager Jobs Near Bridgewater, NJ

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Salary Range

$90K

$225K

Average Salary: $168,000
Manager, Regulatory Affairs

Critically review regulatory documents in addition to performing quality control review for accuracy, completeness, and conformance to appropriate regulations, guidelines, and SOPs...

Posted 6d ago

  •   Less than 5 years exp.  •  Pharmaceuticals & Biotech

Sr. Manager, Regulatory Affairs (CMC)

Knowledge of pharmaceutical industry regulatory affairs CMC discipline throughout the product lifecycle, with awareness of preclinical, clinical, commercialization, and operations...

Posted 4d ago

  •   8 - 10 years exp.  •  Pharmaceuticals & Biotech

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

Establishes and monitors Key Performance Indicators (KPIs) to gauge the overall performance of the Regulatory Affairs team and supporting business processes...

Posted Today

  •   11 - 15 years exp.  •  Healthcare

Director, Regulatory Affairs- CMC

Lead all RA-CMC operations through all phases of clinical development; from FIH through post-approval maintenance.

Posted Yesterday

  •   15+ years exp.  •  Pharmaceuticals & Biotech

Sr. Associate, Regulatory Affairs
$80K — $100K

Performs thorough review of peer submissions to ensure submission quality and compliance with current guidance and regulations. Serves as first line expert in fielding regulatory questions for the or...

Posted 3d ago

  •   5 - 7 years exp.  •  Pharmaceuticals & Biotech

Vice President, Regulatory Affairs

Work closely with the executive leadership team to lead the development of regulatory strategies and objectives that result in the successful registration and post-approval commercialization of Rocket...

Posted 1w ago

  •   15+ years exp.  •  Pharmaceuticals & Biotech

Senior Manager Regulatory Affairs

Accountable for ensuring the completeness and accuracy of all regulatory submissions. Responsible for the planning, preparation and submission of regulatory documentation...

Posted 2w ago

  •   5 - 7 years exp.  •  Pharmaceuticals & Biotech

Associate Director, Regulatory Affairs - CMC

Participate in the preparation of responses to questions from Regulatory Authorities; interface with functional areas to identify and obtain information required for regulatory submissions...

Posted 1w ago

  •   5 - 7 years exp.  •  Pharmaceuticals & Biotech

Sr. Director / Director, Regulatory Affairs

The Sr. Director will be responsible for providing global regulatory leadership in support of the development, registration, and life-cycle management of our innovative gene therapy programs, as well...

Posted 1w ago

  •   11 - 15 years exp.  •  Pharmaceuticals & Biotech

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Associate Director / Director, Regulatory Affairs
$200K — $350K + tbd

Provide regulatory leadership and guidance to Commercial teams during the development, review and approval of product labeling and advertising materials; provide a leadership role on the review commit...

Posted 2w ago

by Jitendra Kushwah

  •   8 - 10 years exp.  •  Pharmaceuticals & Biotech

Associate Director, Regulatory Affairs CMC

Knowledge of pharmaceutical industry regulatory affairs CMC discipline throughout the product lifecycle, with awareness of preclinical, clinical, commercialization, and operations...

Posted 2w ago

  •   11 - 15 years exp.  •  Pharmaceuticals & Biotech

Director, Regulatory Affairs- Advertising & Promotion Compliance

Ensures the maintenance of paper and electronic records of all submissions and communications with OPDP, and any supporting documentation.

Posted Yesterday

  •   11 - 15 years exp.  •  Pharmaceuticals & Biotech

Director, Regulatory Affairs - CMC

Contribute to scientific discussions and collaborations with scientists to resolve technical and regulatory issues in drug substance synthesis, management of impurities and degradation products, formu...

Posted 2w ago

  •   11 - 15 years exp.  •  Pharmaceuticals & Biotech

Associate Director, Regulatory Affairs

Provides regulatory review of advertising and promotional materials, new campaigns and launch strategies for assigned products. Assures timely and accurate review of advertising...

Posted 2w ago

  •   8 - 10 years exp.  •  Pharmaceuticals & Biotech

Senior Director, Oncology Global Regulatory Affairs
$250K — $250K+

Responsible to proactively develop innovative, robust global regulatory strategies for pipeline and lifecycle assets in clinical development through collaborative partnership and leadership of Global...

Posted 1w ago

  •   15+ years exp.  •  Pharmaceuticals & Biotech

Regulatory Affairs Counsel

This position is responsible for providing legal representation to SJI Utilities, Inc. (the “Company”), including the two primary regulated gas utility subsidiaries (South Jersey Gas Company and Eliza...

Posted 3w ago

  •   8 - 10 years exp.  •  Energy & Utilities

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Regulatory Affairs Manager
$130K — $140K
Global Channel Management, IncMadison, NJ 07940 (MORRIS County)

Manage a team, think logically, Should understand FDA requirements, basic reporting, logical attitude; create, plan and implement group goals, objectives and practices for effective, efficient and cos...

Posted more than 4w ago

by Ella Francis Lee

  •   5 - 7 years exp.  •  Pharmaceuticals & Biotech

Associate Director, Global Regulatory Lead, Global Regulatory Affairs

Maintain knowledge of global competitive landscape, regulatory environment, regulations and guidances.

Posted 2w ago

  •   8 - 10 years exp.  •  Pharmaceuticals & Biotech

Manager Regulatory CMC
$100K — $150K

Provide guidance, lead/co-lead projects, manage own time to meet objectives, and plan resource requirements for projects across the department.

Posted 1w ago

  •   5 - 7 years exp.  •  Pharmaceuticals & Biotech

Associate Director, Advertising and Promotion Regulatory Affairs

Ensure consistent application of FDA advertising and promotion regulations, and guidance's across product portfolio lines and compliance with Ferring policies and procedures whilst remaining consisten...

Posted 2w ago

  •   5 - 7 years exp.  •  Pharmaceuticals & Biotech

Director, Regulatory Affairs - Oncology

Review and provide final approval of Worldwide Marketing Applications, Clinical Study Reports, protocols, and Investigator Brochures before release from our Company to external stakeholders...

Posted 3w ago

  •   11 - 15 years exp.  •  Pharmaceuticals & Biotech

Scientist, Regulatory & Scientific Affairs
$100K — $150K

Demonstrate an understanding of jurisdictional coverage, regulatory requirements, and other factors enabling permissibility of sale within a product category for a particular market. Advise the busine...

Posted 3w ago

  •   11 - 15 years exp.  •  Food & Beverages

Director, Regulatory Affairs

Contribute to scientific discussions and collaborations with scientists to resolve technical and regulatory issues in drug substance synthesis, management of impurities and degradation products, formu...

Posted more than 4w ago

  •   11 - 15 years exp.  •  Pharmaceuticals & Biotech

Regulatory Affairs Manager

Maintains awareness of all regulatory activities on assigned projects while working to minimize regulatory issues and helps prevent unnecessary regulatory delays...

Posted more than 4w ago

  •   5 - 7 years exp.  •  Staffing

Manager, Regulatory Affairs CMC (Biologics - Large Molecule))

Provides input to senior Regulatory Affairs CMC professionals in the preparation of country specific labeling and for ensuring product packaging and associated information is updated and maintained in...

Posted more than 4w ago

  •   8 - 10 years exp.  •  Pharmaceuticals & Biotech

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