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Senior Director, Regulatory Affairs

Cambridge, Massachusetts 02142

Post Date: 04/19/2018 Job ID: 1909 Job Category: Clinical: Regulatory

Our client is seeking a Sr. Director, Regulatory Affairs. As a member of the program teams, they will provide strategic guidance regarding FDA and ex-US regulatory requirements for global clinical development and registration of pharmaceuticals.

Responsibilities
  • Compile, review, approve and submit clinical trial and marketing registration applications, amendments, and supplements.
  • Manage and ensure compliance with all reporting requirements, including annual and periodic reports.
  • Organize and manage regulatory meetings with health authorities.
  • Review materials for compliance with advertising and promotion regulations.
  • Perform regulatory strategic assessments for new product candidates and new indications.
  • Provide strategic guidance for and author applications related to designations for expedited programs (e.g. Fast Track, Breakthrough, Priority) or special status (e.g. Orphan).
  • Manage contract staff and vendors as needed to support regulatory activities.
  • Provide create and innovative solutions while being an advocate for compliance.


Requirements:
  • 10-15 years of experience in Regulatory Affairs related to development of pharmaceuticals, CNS experience preferred
  • Bachelor of Science in a scientific discipline, MS or PhD preferred
  • Strong knowledge of eCTD elements and structure
  • Strong regulatory writing skills and use of Microsoft Word
  • Experience working with all levels of management and consulting with key business stakeholders. An ability to influence for greater outcomes.
  • Strong team player that has a customer service approach and is solution oriented.
  • Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
  • Possesses strong written and verbal communication skills.

 

 

Demeika Roberts

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