Regulatory Affairs Manager Jobs Near Bridgewater, NJ

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

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

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

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

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...

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...

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

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

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...

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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...

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

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

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...

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

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

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...

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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...

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

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

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...

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

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...

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...

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

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...