Regulatory affairs jobs in Hoboken, 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...

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...

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...

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...

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...

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...

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, 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...

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 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...

May represent the regulatory affairs function on Global Project Teams and be responsible for developing and implementing regulatory strategy (US and/or global) to achieve regulatory approvals and competitive product labels. Develop and direct implementation of global regulatory strategy for assig...

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...

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...

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. ...

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...

Support the Regulatory Affairs Therapeutic Area Head for IN&F in this strategic leadership position responsible for leading and developing the global regulatory strategies, overseeing health authority interactions and for providing oversight for the preparation, review and evaluation of submissio...

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...

Executive Director Regulatory Affairs - Companion Diagnostics amp Precision Medicine. Significant experience in regulatory affairs and diagnostic related development (e. Experience with communicating the regulatory strategy, issues, and risks in written and verbal format to regulatory senior lead...