Trabajos regulatory affairs en Hackensack, New Jersey (NJ) State

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...

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 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, 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...

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...

Regulatory affairs strategy experience and understanding of CMC, nonclinical and clinical development. Responsible for developing and implementing short and long term global regulatory strategies that support the success of investigational and marketed pharmaceutical products throughout their lif...

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 Regulatory Affairs Labeling Senior Associate is a key member of the Regulatory Affairs Labeling team and will report directly to the Regulatory Affairs Labeling Director. The Regulatory Labeling Senior Associate will be responsible for the development/revision of labeling content along with t...

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...

Regulatory affairs strategy experience and understanding of CMC, nonclinical and clinical development. Responsible for developing and implementing short and long term global regulatory strategies that support the success of investigational and marketed pharmaceutical products throughout their lif...

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...

Step into the realm of regulatory strategy and compliance as the Assistant Director of Regulatory Affairs. Assistant Director Regulatory Affairs. Assistant Director of Regulatory Affairs. Get notified about new Director of Regulatory Affairs jobs in. ...

Keeps current with latest Health Authority guidelines and provides Regulatory advice to members within Regulatory, and various associated departments within the Company. More Years of relevant pharmaceutical experience including 5 years of experience within Regulatory Affairs. Responsible for lea...

Develop an efficient and high value-added Japan regulatory development strategy in line with global strategies Responsible as a contact parson with regulatory authorities (MHLW and PMDA, etc. Develop an efficient and high value-added Japan regulatory development strategy in line with global strat...

Specialist Regulatory Affairs Fort Lee , New Jersey Apply Now. As the US Product Owner (USPO), responsible for the maintenance of the US dossiers and the execution of lifecycle and regulatory compliance activities of the assigned licensed products in line with business targets and regulat...

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 Companion Diagnostics in Basking Ridge at Daiichi Sankyo. More Years relevant pharmaceutical experience including experience within Regulatory Affairs. Leadership responsibility for global regulatory strategy to support the development of biomarkers, companion d...

The individual will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory support across all global projects; meet aggressive deadlines to ensure that regulatory agencies receive timely and quality submissions, shortening the review process and le...

The Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products. Responsibility will mainly focus on Clinical Regulatory filings and provide regulatory leadership on the project teams in this area. Utilize regulatory expertise and knowledge of reg...

Regulatory and QA Specialist Our client is a highly regarded manufacturer of flavors and essential oils. It is located in northern NJ. We have been working with this company for a number of years and ...

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...

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...

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...