Trabajos regulatory affairs en Union, 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 ideal candidate will come with a strong background in Regulatory Affairs from within the Medical Device industry. At least 5 years of Regulatory Affairs experience working with Medical Devices (Class I-III). ...

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...

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...

Our client, a clinical stage biotech company, is seeking an experienced and dynamic Head of Regulatory Affairs to join their growing team. This exciting opportunity offers the chance for a leader with clinical regulatory affairs experience to take on a hands-on leadership role. This role requires...

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...

We are seeking a highly skilled and experienced Regulatory Affairs Specialist to join the ACCU Reference team. Prepare and maintain regulatory submissions, technical files, and regulatory reports. Minimum of 5 years of experience in regulatory affairs, with a focus on FDA submissions and IVD prod...

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...

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 ...

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 expert support IVDR teams, implements regulatory strategies for IVDR activities; provides regulatory leadership; collaborates with the regulatory staff from other business units, companies, government agencies as needed to develop harmonized policies, procedures and work instructions f...

Position Title: Senior Scientist I,Regulatory Affairs. We are seekinga Senior Scientist - Regulatory tojoin our Regulatory team inour Clark, NJ Researchfacility. This role is responsible for supportingthe Hair product team on regulatory compliance and regulatoryreporting/registration requirements...

Prepare new/revised label packaging for regulatory submissions to the USDA and maintain regulatory documents to ensure site compliance. Support regulatory filing submissions with the USDA for both domestic and international product packaging. ...

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...

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...

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

Specialist, Regulatory Affairs. Specialist, Regulatory Affairs to join our team. The candidate will be responsible for providing expert support in applicable team meetings and when consulted, and operate as a SME regarding regulatory guidances/regulations and strategies to other members of the re...

As the Senior Manager, Regulatory Affairs you will be responsible for the development and execution of US regulatory strategy for projects within an assigned Therapeutic Area (“TA”). Develop and execute US regulatory strategy, with oversight as needed, and in conjunction with Global Regulatory Le...

The Associate Director US Regulatory Affairs CMC is responsible for creation and implementation of CMC regulatory strategies to support the Bayer’s development and marketed product portfolios. Associate Director US Regulatory Affairs CMC. The primary responsibilities of this role, Associate Direc...

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...

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...

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...

Director Regulatory Affairs and Value Added Services. Establish links with relevant regulatory authorities toreceive regulatory updates on new and proposed legislation that may impact thebusiness. Tolead and manage the strategic and operational performance of the Quality,Regulatory and Documentat...

Provide leadership for and manage regulatory aspects of the LMR review / approval process for product promotional materials, maintain compliance of promotional materials with the governing FDA regulations, and submit promotional materials to OPDP in a timely fashion;Provide risk assessment and mi...