Regulatory Affairs Manager: Average Salary in Trenton, NJ in 2024

A Manager is responsible for activities related to regulatory publishing and submission support to FDA and other regions accepting eCTD. Work with regulatory document authors to achieve resolution and ensure that documents comply with regulatory and company guidance/template specifications. Supports...

A company is looking for a Regulatory Manager to join their Corporate Counsel team. ...

Write Regulatory documents translating team strategy into regulatory overview documents such as cover letters, pre-meeting package, and other US specific regulatory positioning documents to assist Project Leaders in support of business needs. Develop and maintain positive rapport and working relatio...

Manages team and leads Regulatory Associates and/or Senior Regulatory Associates in regulatory activities associated with planning, authoring, compiling and submitting highest-quality regulatory submissions to the FDA within company timelines and in accordance with regulatory guidelines and applicab...

Regulatory Affairs Manager/Personal Care-Princeton. Regulatory Affairs Manager/Personal Care. As a Regulatory Affairs Manager North America (NA), you will be part of a cross-functional team located in North America, working closely with a Global team in Switzerland. Lead and manage NA regulatory act...

A Manager is responsible for activities related to regulatory publishing and submission support to FDA and other regions accepting eCTD. Work with regulatory document authors to achieve resolution and ensure that documents comply with regulatory and company guidance/template specifications. Supports...

A Manager is responsible for activities related to regulatory publishing and submission support to FDA and other regions accepting eCTD. Work with regulatory document authors to achieve resolution and ensure that documents comply with regulatory and company guidance/template specifications. Supports...

Prepare and submit CTAs within the EU Clinical Trial Integrated System (CTIS) and MHRA Integrated Regulatory Submission (IRAS) submission portals in accordance with regulatory requirements, using Submission Management tools and an EDMS system. Assist with the development of assigned regulatory opera...

Prepare and submit CTAs within the EU Clinical Trial Integrated System (CTIS) and MHRA Integrated Regulatory Submission (IRAS) submission portals in accordance with regulatory requirements, using Submission Management tools and an EDMS system. Assist with the development of assigned regulatory opera...

Regulatory & Medical Affairs - Regulatory Studio - CMC Senior Manager. Work with CMC cross-functional teams and Regulatory Affairs teams. Participate in the development of the CMC regulatory strategy for post-approval small molecule product submissions, including global supplements/variations an...

The Senior Manager, Regulatory Affairs will handle publishing and coordinating tasks for Global RA submission activities. Review and track the archiving of global eCTDs , paper submissions and Health Authority correspondences using Regulatory Affairs systems/tool. Publish, review, submission and arc...

Supervise, review and approval of labeling for marketed products Track applications through FDA reviewing divisions Work with project associate on compilation of information and supportive documentation for FDA briefing packages Work with project leader and team to draft FDA meeting requests and sup...

Our client is looking to fill the role of CMC Regulatory Affairs Manager. Provide CMC regulatory strategy for investigational, new and marketing products (biologics and small molecule focus). Responsible for determination of regulatory and scientific/technical requirements for CMC and GMP related su...

Write Regulatory documents translating team strategy into regulatory overview documents such as cover letters, pre-meeting package, and other US specific regulatory positioning documents to assist Project Leaders in support of business needs. Develop and maintain positive rapport and working relatio...

The Senior Manager Regulatory Affairs will play a critical role within Philips’ Clinical Informatics organization by leading regulatory projects for Philips’ Disease Management Solution products, ensuring and maintaining global accurate regulatory strategy and market access, directly impacting the l...

Regulatory & Medical Affairs - Regulatory Studio - CMC Senior Manager. Work with CMC cross-functional teams and Regulatory Affairs teams. Participate in the development of the CMC regulatory strategy for post-approval small molecule product submissions, including global supplements/variations and re...

Manages team and leads Regulatory Associates and/or Senior Regulatory Associates in regulatory activities associated with planning, authoring, compiling and submitting highest-quality regulatory submissions to the FDA within company timelines and in accordance with regulatory guidelines and applicab...

Our client, a growing pharmaceutical company, has engaged GForce to provide a CMC Regulatory Affairs Manager Consultant. The role will be focused on providing CMC regulatory strategy input and expertise around investigational, new, and marketed biologic and small molecule drug products to assigned p...

Prepare and submit CTAs within the EU Clinical Trial Integrated System (CTIS) and MHRA Integrated Regulatory Submission (IRAS) submission portals in accordance with regulatory requirements, using Submission Management tools and an EDMS system. Assist with the development of assigned regulatory opera...

Manager/Associate Director, Regulatory Affairs Strategist. Manager/Associate Director, Regulatory Strategist is responsible for the assigned branded programs and all strategic decisions to include providing regulatory pathway for the development, preview of clinical, non-clinical and CMC development...

The Regulatory Affairs Manager will be responsible for ensuring compliance with all regulatory standards and guidelines, leading the preparation and submission of regulatory documents including CMC modules, and overseeing the development of generics including Risk Evaluation and Mitigation Strategie...

The Manager will collaborate closely with the Director and VP of Regulatory Affairs, focusing on tasks such as regulatory submissions, initiating and reviewing change controls, and managing labeling activities. This role is responsible for preparing and reviewing a variety of regulatory submissions ...

Write Regulatory documents translating team strategy into regulatory overview documents such as cover letters, pre-meeting package, and other US specific regulatory positioning documents to assist Project Leaders in support of business needs. Develop and maintain positive rapport and working relatio...

Work with CMC cross-functional teams and Regulatory Affairs teams. PREREQUISITES BS/BA degree in Scientific Discipline (master's or higher preferred) with + years in the pharmaceutical industry, preferably with + years CMC regulatory experience, Sterile Injectable experience preferred. Participate i...

A Manager is responsible for activities related to regulatory publishing and submission support to FDA and other regions accepting eCTD. Work with regulatory document authors to achieve resolution and ensure that documents comply with regulatory and company guidance/template specifications. Supports...