Manager, Regulatory Affairs

San Rafael, CA 94901

Posted: 05/24/2020 Employment Type: Contract Industry: Regulatory Affairs & Compliance Job Number: 7842

Job Description


Our client focuses on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases.

 

Duties: 

The Manager in Regulatory Affairs, Clinical/Nonclinical, will be responsible/accountable for:
  • Preparing clinical/nonclinical global regulatory submissions in accordance with applicable regulations, including the following:
  • INDs or international equivalents and amendments
  • NDAs, BLAs, or international equivalents and amendments
  • Information related to clinical trials including protocols, investigator brochures and investigator information
  • Annual Reports
  • Representing the Regulatory Affairs function on assigned cross-functional project teams and to external partners
  • Actively participate in regulatory sub-teams and lead meetings on defined topics with a clear objective
  • Researching and interpreting global regulations to provide regulatory guidance to cross-functional groups
  • Proactively identify and communicate potential regulatory issues/risks and recommend solutions to Regulatory Affairs management
  • Assist in coordination of meetings with Regulatory Authorities and associated briefing document preparation, as needed

 

Job Requirements

Skills:    

  • 3-4 years of experience in Regulatory Affairs or related discipline in the pharmaceutical or biotechnology industry, preferably with exposure to the development phase of the product lifecycle
  • Experience in management and submission of clinical/nonclinical global regulatory documents
  • Experience in participating and representing Regulatory Affairs on clinical study management teams 
  • Thorough understanding of relevant clinical/nonclinical ICH and regional regulatory requirements, particularly for the development phase of product development
  • Excellent communication (verbal and written) and interpersonal skills with the ability to communicate cross-functionally in a collaborative manner
  • Attention to detail

 

Education:          

  • BA/BS degree in life sciences required.  Advanced degree preferred.
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