Regulatory affairs jobs in Piscataway, New Jersey (NJ) State

Facilitate and maintain correspondence with the FDA on behalf of sponsor which may include hosting meetings, phones, calls and/or other necessary regulatory documentation. * Ensure regulatory ...

Senior Director, Global Regulatory Affairs Strategy The position will provide regulatory affairs strategic leadership for the company and novel drug development programs. Of each program this position supports, the individual will be responsible for developing and executing the overall regulatory...

Global Regulatory Affairs Operation（Sr. This position belongs to Global regulatory affairs department, serving the global Market which encompasses China US, EU, AUS and others. This role requires a detail-oriented professional who can oversee all regulatory affairs and quality assurance activitie...

DOWNLOAD OUR CODE OF CONDUCT 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. Pub...

The Director of Policy and Regulatory Affairs will be responsible for managing Elevate’s relationships and policy positions at PJM, federal and state regulatory agencies, and state legislative bodies. Director of Policy and Regulatory Affairs – PJM Region. The position reports to the Vice Preside...

DOWNLOAD OUR CODE OF CONDUCT 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. Pub...

The Director, Regulatory Affairs should have an advanced degree, preferably in the sciences, and have demonstrated application of regulatory expertise by at least 8+ years pharmaceutical industry experience. A long term consulting client of X4 Life Sciences is looking to add a Regulatory Affairs ...

Manager of Regulatory Affairs Strategy to join their team. Serves as a liaison to FDA and provides strategic input with the regional regulatory leads responsible for ex-US regulatory activities. This role is responsible for developing, implementing, and leading short/long term global regulatory s...

Looking for a unique approach to Regulatory Affairs? Want to push boundaries and bring life-saving medicine to the marketplace? This is the role for you!. My client is a multinational CDMO looking for a Regulatory Affairs Manager to work with the FDA and their client sites to manufacture generic ...

Our client, an exciting and growing Biotech Company, is seeking a Regulatory Affairs professional at the Senior Director level. Launch the company's regulatory strategy having leadership over all regulatory activities. This role will lead the North America regulatory strategy and work extremely c...

The incumbent responsible for supporting the development and implementation of regulatory strategies, work closely with the cross functional asset teams to prepare, review and submit regulatory filing documents, manage documentation systems and maintain interactions with regulatory agencies. This...

Responsibilities Develop and execute novel drug regulatory strategy Ensure development programs are compliant with ICH regulatory requirements and all local country regulatory requirements Strong project management skills and strong interpersonal skills to handle complex distributed programs Abil...

Coordinate with the team to monitor the progress of certain products submitted by Ostend Regulatory Affairs departments. Coordinate regulatory activities with internal teams and external regulatory agencies. Manage the day-to-day activities of less senior Regulatory Affairs professionals, includi...

The Senior Associate, Regulatory Affairs is responsible for supporting applications under pre and post approval conditions. Under the direction of Regulatory Affairs management, participate in drug development from early stage development through final formulation, ensuring compliance with princi...

Job title: Senior Manager, US Advertising & Promotion, Global Regulatory Affairs**+ Location: Bridgewater, NJ or Cambridge, MAAbout the jobWe are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. Ready to get started?Under th...

Proven and relevant regulatory affairs experience in pharmaceutical, vaccine, or biological products; or related fields. Knowledge on relevant regulatory guidelines VICH guideline, USP, EU, ICH guidelines and relevant applications. Lead development and execution of global product and project regu...

This role will be accountable for leading the development and execution of innovative and value-added global regulatory strategies and be responsible for formulating the Global Regulatory Project Strategy (GRPS) for immunology products in Early Development. At least - years of relevant pharmaceut...

The Manager, Regulatory Affairs - Regulatory Project Management (RPM) provides planning and coordination supports for global and US regulatory activities. The Manager RPM is responsible for supporting the global regulatory lead (GRL), US regulatory lead (USRL) and global regulatory team (GRT) for...

At least - years of relevant pharmaceutical/biotechnology experience in R&D, including at least years of relevant Regulatory Affairs experience (regional and/or global), in early development. This role will be accountable for leading the development and execution of innovative and value-added glo...

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 meri...

As the Director, Regulatory Affairs – Advertising, Promotion and Regulatory Compliance you will be responsible for leading a group of US Regulatory Affairs professionals responsible for advertising and promotion, compliance, labeling and submission operations within US RA. Coordinate regulatory p...

The Global Regulatory Affairs Lead (GRL) is the fully accountable decision maker for the development & execution of creative, thoughtful, and robust global regulatory strategies for their products in Sanofi’s diversified portfolio in order to meet corporate and business objectives. At least 8-10 ...

As the Associate Director, Regulatory Affairs you will be responsible for leading the development and execution of US regulatory strategy for projects within an assigned Therapeutic Area (“TA”). Lead the development and execution of US regulatory strategy in conjunction with Global Regulatory Lea...

Regulatory Affairs Specialist (Hybrid). Kelly® Science & Clinical is seeking a Regulatory Affairs Specialist for our client in Bridgewater, New Jersey. Experience in Regulatory Affairs preferably Medical Devices, preferably on Global programs. Provide Regulatory Documentation Support to Global R....