Trabajos pharmaceutical regulatory affairs en Newark, New Jersey (NJ) State

Prior experience must include: Develop the regulatory submission strategies for products in commercial and development phase by working in close coordination with the quality, manufacturing and global regulatory teams; Ensure the response to health authority queries are provided in a timely and e...

Manager, Global Regulatory Affairs CMC Submissions Management in Lexington, MA with the following requirements: Bachelor’s degree in a scientific field or foreign academic equivalent plus 4 years of related experience. Required skills: Ability to work with firm deadlines and adapt quickly to chan...

QualificationsMsc/MPharm/BPharm with a Scientific or Regulatory background or equivalent combination of education and experience Total years of experience required for the role: 6 to 7 years of US labeling experience, with a focus on NDA 505(b)(2) applications + 1 year supervisory experienceRelev...

The incumbent responsible for supporting the development and implementation of regulatory strategies, work closely with the cross functional asset teams to prepare, review and submit regulatory filing documents, manage documentation systems and maintain interactions with regulatory agencies. This...

The Senior Associate, Regulatory Affairs is responsible for supporting applications under pre and post approval conditions. Under the direction of Regulatory Affairs management, participate in drug development from early stage development through final formulation, ensuring compliance with princi...

The incumbent responsible for supporting the development and implementation of regulatory strategies, work closely with the cross functional asset teams to prepare, review and submit regulatory filing documents, manage documentation systems and maintain interactions with regulatory agencies. This...

QualificationsMsc/MPharm/BPharm with a Scientific or Regulatory background or equivalent combination of education and experience Total years of experience required for the role: 6 to 7 years of US labeling experience, with a focus on NDA 505(b)(2) applications + 1 year supervisory experienceRelev...

The incumbent responsible for supporting the development and implementation of regulatory strategies, work closely with the cross functional asset teams to prepare, review and submit regulatory filing documents, manage documentation systems and maintain interactions with regulatory agencies. This...

The Senior Associate, Regulatory Affairs is responsible for supporting applications under pre and post approval conditions. Under the direction of Regulatory Affairs management, participate in drug development from early stage development through final formulation, ensuring compliance with princi...

The incumbent responsible for supporting the development and implementation of regulatory strategies, work closely with the cross functional asset teams to prepare, review and submit regulatory filing documents, manage documentation systems and maintain interactions with regulatory agencies. This...

The incumbent responsible for supporting the development and implementation of regulatory strategies, work closely with the cross functional asset teams to prepare, review and submit regulatory filing documents, manage documentation systems and maintain interactions with regulatory agencies. This...

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 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...

The Associate 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 knowle...

The responsibilities include providing US regulatory leadership and direction for Rocket’s gene therapy products, including developing long and short-term planning of regulatory projects that align with the company's business plan, and developing strategies to ensure effective achievement of regu...

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...

The Manager, Regulatory Affairs will report to the Global Regulatory Liaison (GRL) and provides support to the GRL in all aspects of regulatory affairs related to the development of novel therapeutics including quality, preclinical and clinical areas of drug development and the policies/procedure...

Specialist, Regulatory Affairs. Specialist, Regulatory Affairs to join our team. The candidate will be responsible for providing expert support in applicable team meetings and when consulted, and operate as a SME regarding regulatory guidances/regulations and strategies to other members of the re...

Manager, Regulatory Affairs will report to the Global Regulatory Liaison (GRL) and provides support to the GRL in all aspects of regulatory affairs related to the development of novel therapeutics including quality, preclinical and clinical areas of drug development and the policies/procedures re...

As the Director, Regulatory Affairs CMC you will be responsible for developing and implementing regulatory strategies for US CMC activities throughout the product lifecycle. CMC Regulatory Strategy: Partner with key stakeholders to develop and implement CMC regulatory strategies and plans for CMC...

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...

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...

The Associate II assists with minimal guidance, the Director of Specialty Regulatory Affairs with all IND/NDA related activities. Master Degree (MS/MA) Regulatory Affairs or Science - Preferred. Compilation of regulatory submissions including INDs, NDAs, amendments and supplements and manage subm...

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...