Associate Director, Regulatory Affairs

We have been retained to find top-tier candidates for a newly created Regulatory Affairs Associate Director position.  My client is a commercial-stage biopharmaceutical company which is committed to transforming the lives of patients with cancer and rare genetic diseases. In this position, you will play a key role in creating innovative long-range regulatory strategies to expedite the development of first-in-class pipeline programs. With two approved programs and multiple investigational therapies in development, now is an ideal time to join this growing company!

Responsibilities:

  • Develop and execute regulatory strategy for long-term planning including expedited development needs
  • Act as primary interface with the local health authorities
  • Organize and drive preparation for health authority meetings and teleconferences
  • Prepare and coordinate regulatory submissions (ie clinical trial and marketing applications, formal meeting documentation, life-cycle management submissions)
  • Collaborate effectively with cross-functional teams and define regulatory expectations
  • Provides insight and guidance regarding the implementation of current regulations and assess regulatory risk based on precedence

Requirements:

  • Bachelor’s degree in life-sciences or related scientific discipline; advanced degree preferred
  • Must have a minimum of five years in the pharmaceutical industry with two or more years of regulatory affairs experience
  • Demonstrated knowledge of FDA, EMA and ICH guidelines and regulations with specific expertise in drug development
  • Previous experience preparing and reviewing INDs, CTAs, NDAs, etc.
  • Experience preparing briefing books and meeting requests for health authorities
  • Excellent organizational and communication skills, both written and verbal
  • Ability to work independently as well as part of a team environment
  • Proven ability to manage multiple projects and resolving regulatory issues
  • Positive, energetic, and proactive attitude

 

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