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

Regulatory Affairs SpecialistPosition This hire will be a member of the Firm’s Regulatory group which is responsible for exam oversight, branch inspections, regulatory change tracking, governance related tasks and additional ad-hoc tasks. The Firm’s Regulatory Group is housed within its Legal Dep...

Key outcomes include building awareness, acceptance and adoption of PMI, project management standards and certification in government, and raising the profile of project management as a discipline. You will work with government entities which influence policy making, regulatory affairs, and legis...

Our client, a Reputable, Global Pharmaceutical Company, is seeking a Regulatory Affairs Strategy professional at the Director level. The position will report directly into the VP of Regulatory Affairs. Develop and implement Regulatory Affairs strategy for Oncology programs. Regulatory Affairs Str...

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 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...

As the Senior Vice President/Head of Regulatory Affairs, you will play a pivotal role in shaping the regulatory strategy and ensuring compliance for their portfolio of ophthalmic products. Oversee the preparation, submission, and management of regulatory submissions, including INDs, NDAs, BLAs, a...

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...

Job Title: Lead Regulatory Affairs. Ensure development programs are compliant with ICH regulatory requirements and all local country regulatory requirements. Ability to author clear and concise regulatory documents (CMC authoring) with oversight of all documents for regulatory submissions and ass...

Advanced degree in life sciences, pharmacy, or a related field; PhD or PharmD preferred. ...

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...

As the Senior Vice President/Head of Regulatory Affairs, you will play a pivotal role in shaping the regulatory strategy and ensuring compliance for their portfolio of ophthalmic products. Oversee the preparation, submission, and management of regulatory submissions, including INDs, NDAs, BLAs, a...

Job Title: Lead Regulatory Affairs. Ensure development programs are compliant with ICH regulatory requirements and all local country regulatory requirements. Ability to author clear and concise regulatory documents (CMC authoring) with oversight of all documents for regulatory submissions and ass...

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...

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...

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...

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). ...

Our client, a Reputable, Global Pharmaceutical Company, is seeking a Regulatory Affairs Strategy professional at the Director level. The position will report directly into the VP of Regulatory Affairs. Develop and implement Regulatory Affairs strategy for Oncology programs. Regulatory Affairs Str...

Coordinates the collection of documents, records, reports, and data from the Development, Clinical Affairs, Quality, and Operations Departments for inclusion in regulatory documents. Responsible for the coordination and preparation of document packages for regulatory submissions from all areas of...

Coordinates the collection of documents, records, reports, and data from the Development, Clinical Affairs, Quality, and Operations Departments for inclusion in regulatory documents. Responsible for the coordination and preparation of document packages for regulatory submissions from all areas of...

Johnson & Johnson Innovative Medicine is recruiting for a Director, Global Regulatory Affairs ... Bring innovative regulatory approaches, deeply rooted in science, to lead the team in discussions ...

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...

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...