Regulatory affairs jobs in Elmwood Park, New Jersey (NJ) State

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...

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 ...

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...

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...

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...

Associate Director/Director, Regulatory Affairs (Oncology). This role will be reporting into the VP of Regulatory Affairs and will be serving as the Lead for a US Phase III Oncology program. Serve as SME for US Regulatory Affairs in cross-functional groups. They are looking for an Associate Direc...

Regulatory Affairs Labeling Associate Level I is needed to support Client business to prepare and review regulatory labeling deliverables based on Reference Listed Drug labeling, FDA Guidance, regulation and Client internal practices. Applying strategic thinking, pharmaceutical educational kno...

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...

Prepare new and maintain existing regulatory files in accordance with regional requirements, including but not limited to document updates, management of regulatory information in databases, and navigating document control systems. Review regulatory content for completeness, accuracy, consistency...

The Senior Regulatory Affairs Associate/Manager plays a key role in ensuring compliance with regulatory requirements that govern the development, registration and commercialization of livestock and poultry products (primarily medicated feed additives and water-soluble products) while also providi...

Job Title: Regulatory Affairs Specialist. The Regulatory Affairs Specialist will be instrumental in CRM cleanup and data migration tasks. ...

The Regulatory Affairs Project Manager is responsible for ensuring that the company aligns with all of the regulations and laws pertaining to our business; Working with federal, state, and local regulatory agencies on specific issues affecting our business; and advises the company on the regulato...

Job Title: CMC Regulatory affairs / Animal Health Care. 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 deve...

Our client is currently seeking a Senior Manager, Regulatory Affairs. Represent regulatory affairs on project teams and support R&D and clinical research activities. Regulatory Affairs Certified is a plus. Develop and implement global regulatory strategies for investigational and marketed pharmac...

Eligibilities & qualifications....

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...

You will participate on cross-functional teams, develop global regulatory strategies, author regulatory submissions, interacts with regulatory agencies/notified bodies, review labeling and marketing materials, and evaluates proposed device changes. Here are 10 reasons to join our Regulatory Affai...

Reporting to the Vice President of Global Regulatory Affairs (GRA), the Director of Chemical and Biological Regulatory Affairs will be responsible for setting the strategy for and leading the Chemical/Biological Regulatory Affairs team within the Global Regulatory Affairs organization. Assists in...

Regulatory Affairs Senior Manager is responsible for leading the regulatory strategy and managing the regulatory compliance in Personal Care and Cosmetics. This position will report directly to the Global Director Regulatory Affairs. Lead and enhance the regulatory program to enable the business ...

Assesses regulatory pathways for new products, product modifications or product conversions; develops regulatory strategies and planning for submissions or support of customers’ regulatory submissions. Acts as a RA Core team Member (RA CTM) and works with RA Manager and Platform Leaders to ensure...

Regulatory Strategy Development: Lead the development and implementation of regulatory strategies aligning with business priorities and regulatory standards. Regulatory Compliance/Intelligence Oversight: Monitor regulatory developments and stay abreast of industry best practices in the animal hea...

Our client is currently seeking a Senior Manager, Regulatory Affairs Strategy. Regulatory Affairs Certified is a plus. Responsible for developing and implementing short and long term global regulatory strategies that support the success of investigational and marketed pharmaceutical products thro...

Manages F&B Naturals Regulatory Affairs team and and coordinates with F&B Flavor Regulatory Affairs team to ensure regulatory compliance of Naturals products with corporate guidelines and government regulations. Minimum 3-5 in regulatory affairs. Works independently to provide customers with prod...