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

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...

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, 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...

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...

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 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). ...

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...

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...

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). ...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

Director Regulatory Affairs and Value Added Services. Director Regulatory Affairs and Value Added Services. Director Regulatory Affairs and Value Added Services. Establish links with relevant regulatory authorities toreceive regulatory updates on new and proposed legislation that may impact thebu...

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...

We are conducting a search for a Director of Regulatory Affairs for a food/beverage company in New Jersey. Candidates must have a degree in Food Science or related. A Masters degree is a plus. The ...

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...