Regulatory Affairs Senior Manager/ Associate Director

My client is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious and life-threatening rare and genetic disease.  They are seeking a Regulatory Affairs Sr. Manager or Associate Director to help shape a cohesive regulatory strategy across several clinical development programs.  You will ensure effective integration of broad regulatory ideas and tactics supporting franchise strategy while reporting directly to the Vice President of Regulatory Affairs.  The ideal professional is someone who possesses a flexible nature, and is a science minded thinker with well-developed communication skills.

Responsibilities:

  • Contribute to the development of regulatory strategy for multiple projects in development
  • Serve as regulatory lead for assigned projects
  • Work with Global Regulatory Program Leads and Regional Representatives to ensure unified regulatory input with cross-functional development teams, clinical programs, and commercial strategy
  • Communicate regulatory strategy, risks, and mitigations to the global regulatory team
  • Anticipate global regulatory changes and develops proactive strategy accordingly
  • Review and approve regulatory submission documents and Health Authority communications
  • Represent Global Regulatory Affairs on cross functional teams

Knowledge and Skills:

  • Bachelor’s degree in relevant scientific discipline required. Advanced degree desirable.
  • A minimum 5 years pharma experience, with 3+ years in Regulatory Affairs.
  • Must have experience working on original INDs, CTAs, BLAs, and/or MAAs.
  • Experience with developing and implementing competitive regulatory strategies.
  • Must have experience working on biologic programs. Gene therapy experience a plus.
  • Strong experience working with the US FDA is required. Experience with Health Canada and other health authorities preferred.
  • Knowledge of US and EU regulatory procedures including legislation for drug development and product registration.

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