Trabajos regulatory affairs en West New York, 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...

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 ...

Looking for a unique approach to Regulatory Affairs? Want to push boundaries and bring life-saving medicine to the marketplace? This is the role for you!. My client is a multinational CDMO looking for a Regulatory Affairs Manager to work with the FDA and their client sites to manufacture generic ...

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...

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...

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...

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...

The Regulatory Affairs Project Manager is responsible for ensuring that the company aligns with all of the regulations and laws pertaining to our business; Working with federal, state, and local regulatory agencies on specific issues affecting our business; and advises the company on the regulato...

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...

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...

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...

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...

Executive Director - Regulatory Affairs Team Leader - 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 leadership team ...

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...

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...

A rapidly growing biotech/medical device client of X4 Life Sciences is looking for 2 Regulatory Affairs Managers to join their fast-paced organization. Meeting US, EU, Canada & international regulatory requirements. Liaising with Quality, R&D and Manufacturing on regulatory activities. ...

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...

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 Senior Director, Regulatory Affairs - Clinical (Early Development), may be called upon to guide a team of Clinical Regulatory Affairs professionals providing strategic regulatory guidance to cross-functional project teams and responsible for product development and post marketing commitments....

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...

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...

Administer regulatory change program review of vendor tools/applications available for regulatory change monitoring oversee selection/implementation/administration of vendor tool/application if warranted summarize and distribute new/amended rule proposals and rules to internal constituents overse...

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...

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...