Regulatory Associate: Average Salary in Edison, NJ in 2024

This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This position drives/leads the maintenance of global labeling and associated d...

The Associate Director, Regulatory Affairs - Advertising & Promotion will provide strategic regulatory advice on advertising and promotion for assigned products in accordance with business goals and objectives, FDA regulations and guidances, and company policies. Apply regulatory and therapeutic...

The individual will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory support across all global projects; meet aggressive deadlines to ensure that regulatory agencies receive timely and quality submissions, shortening the review process and leadi...

Regulatory Operations Specialists - II (Associate). Perform regulatory information management tasks including file transfer, storing, tracking, and archiving of regulatory submission documents/correspondence into RA SharePoint site and/or ALEXX. The specialist position also works as part of a team t...

The Associate Director, Regulatory Operations – Dossier Planning is responsible for the management and oversight of the US Dossier Planning team. The Associate Director provides leadership and oversight to create submission plans that result in high quality regulatory submissions and procedures incl...

The Senior Associate, Regulatory Operations is responsible for helping to plan, schedule and coordinate regulatory submissions in adherence with technical document standards that are fully compliant with FDA and ICH requirements. They will serve as a system administrator for BPI's US Regulatory elec...

Meet's partenered with a global pharmaceutical manufacturing company on an exciting new search for an Associate Director, Global Regulatory Labeling!. You'll be serving as the GRA labeling experit for the Global Regulatory Team and independently provide strategic and operational leadership on produc...

The Associate Director, Regulatory Operations role is accountable for managing regulatory submission related activities, providing business ownership and management of IT systems within the scope of Regulatory Affairs/Operations. Associate Director Regulatory Operations. The individual will survey e...

Associate Director, Regulatory Legal page is loaded. Associate Director, Regulatory Legal. Providing regulatory interpretations, defending regulatory enforcement actions, and acting as liaison with outside counsel, where appropriate. Associate Director, Regulatory Legal. ...

The Associate Director, Regulatory Operations – Dossier Planning is responsible for the management and oversight of the US Dossier Planning team. The Associate Director provides leadership and oversight to create submission plans that result in high quality regulatory submissions and procedures incl...

Associate Director, Regulatory CMC. Serves as the regulatory CMC representative on core teams, develops and plans regulatory CMC submission strategy with a focus on allogeneic gene-edited products. Coordinates and manages CMC regulatory submissions, applying CMC global regulatory strategies. Facilit...

The Associate Director, Regulatory Affairs - Advertising & Promotion will provide strategic regulatory advice on advertising and promotion for assigned products in accordance with business goals and objectives, FDA regulations and guidances, and company policies. Apply regulatory and therapeutic are...

At Azenta, new ideas, new technologies and new ways of thinking are driving our future.Our customer-focused culture encourages employees to embrace innovation and challenge the status quo with novel thinking and collaborative work relationships.Azenta Life Sciences is a global leader in the life sci...

For this position, the incumbent will be assigned to lead one or two high priority late-phase clinical development programs as Global Regulatory Lead (GRL), responsible for leading regulatory sub-team and all regulatory activities including marketing authorization filing and approval in US and Europ...

The CMC Regulatory Associate Director, Biologics is responsible for content development, compilation, maintenance, and review of the Quality Module for regulatory submissions to support biologics products regarding: Clinical trial applications; New marketing applications; HA responses & background p...

Job title: Associate Director, US Advertising and Promotion, Global Regulatory Affairs**+ Location: Cambridge, MA or Bridgewater, NJ**About the job**The Associate Director, US Advertising and Promotion serves as the regulatory lead on Review Committees (RCs). As the RC Regulatory Affairs representat...

Job title: Associate Director, US Advertising and Promotion, Global Regulatory Affairs. The Associate Director, US Advertising and Promotion serves as the regulatory lead on Review Committees (RCs). As the RC Regulatory Affairs representative, work with brands on competitively positioning assigned p...

Lead the Global Regulatory Matrixed Team in defining and executing the global regulatory strategy for assigned programs to ensure timely and high-quality regulatory deliverables to the GPTs. Present regulatory strategies including communication of regulatory risks and associated mitigation plans to ...

The CMC Regulatory Associate Director, Biologics is responsible for content development, compilation, maintenance, and review of the Quality Module for regulatory submissions to support biologics products regarding: Clinical trial applications; New marketing applications; HA responses & background p...

This role is the key in ensuring the accurate and the timely submission of all Guerbet regulatory documents, staying current on all US federal regulations to ensure compliance, develop training programs and/or communications documents to meet regulatory requirements, and ensure that regulatory proce...

Develop strategic direction and provide leadership for all regulatory interactions with FDA/global regulatory authorities . Those aren’t words that are usually associated with a job. Develop global and/or US regulatory strategy for Oncology products in development and through life cycle management, ...

Responsibilities Actively contribute to the development of regulatory strategies for investigational products in Investigational New Drug (IND)/ Clinical Trial Applications (CTA), Biologics Licensing Application (BLAs)/ Marketing Authorization Application (MAA), through evaluating scientific merits ...

Pharmaceutical company looking for an experienced Quality Assurance and Regulatory Affairs Associate. Under the supervision of the Head of QA/RA, the QA/RA Associate is responsible for assisting the team with the maintenance quality and regulatory policies and procedures that ensure quality complian...

CRM performs work on a variety of regulatory compliance related matters. The CRM team is an oversight control function within BX Central Legal & Compliance designed to assess the effectiveness of BX’ policies and procedures, particularly with respect to regulatory compliance of the BX registered...

The Associate Director, Advertising and Promotion, Prescription Drug Products, reviews, approves and monitors prescription drug product advertising and promotional labeling pieces for compliance with regulatory agency requirements. Implements regulatory strategies and solutions to assure all adverti...