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Regulatory Clinical Trial Application (CTA) Submission Manager

  1. East Coast
New York
  1. Permanent
Competitive
  1. Drug Safety / Pharmacovigilance
29149

This vacancy has now expired

Regulatory Clinical Trial Application (CTA) Submission Manager – Contract – New York

Are you looking for your next career step in Regulatory Affairs? Our client, a household name in the healthcare sector and innovative pharmaceutical organization, are looking for a Regulatory CTA Submission Manager for a contractual position at their New York site.

This position will be responsible for managing regulatory Clinical Trial Applications (CTA) submission activities for assigned clinical trials across  Oncology, Neuroscience, Cardiovascular and Metabolism, Pulmonary Hypertension, Immunology, and Infectious Diseases.

Regulatory CTA Submission Manager Responsibilities:
  • Responsible for the execution of the global CTA submission strategy
  • Responsible for the quality and completeness of the CTA regulatory submissions for Clinical Trial Applications, throughout the lifecycle of the trial.
  • Ensure that the required regulatory intelligence is in place to comply with country-specific requirements
  • Lead a cross-functional team that will compile, publish and produce Clinical Trial Authorization Applications and associated CTA lifecycle submissions.
  • Responsible for interactions with Health Authorities.
Regulatory CTA Submission Manager Responsibilities:
  • Relevant BSc degree in life sciences discipline.
  • In depth regulatory submission experience and regulator knowledge.
  • Experience in project management.
  • Leadership skills.
  • Strong communication skills.
Are you interested in this Regulatory CTA Submission Manager position? Apply today!

The candidate must have the rights to work in the location stated in the job advert.

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