Regulatory Affairs Associate Director or Director

This growing biopharmaceutical company is developing medicines for patients who suffer from serious, rare neurological diseases.  They are seeking a Regulatory Affairs Associate Director or Director who can develop and execute global regulatory strategies for the company’s late-stage program.  Reporting into the Regulatory Affairs Vice President, you will work directly with FDA and other health authorities, while helping to get transformative drugs approved.  This company offers a patient-first culture, flexible PTO, and the ability to work remotely (with some regular visits to their office.)  With their lead program heading into Phase 3 trials, now is an exciting time to join this growing organization! 

Responsibilities:

  • Develop and execute global regulatory strategies for product development, approval, and registration for rare neurological disease programs.
  • Lead and advise cross-functional teams on regulatory strategies that optimize and expedite the development and maximize the probability of success by mitigating anticipated risks.
  • Maintain regulatory applications to ensure compliance with regulations, including the preparation, review, and execution of pre- and post-marketing submission deliverables.
  • Serve as Regulatory lead or co-lead on assigned drug project teams, providing regulatory guidance and recommendations that are in line with the company goals, international laws, and regulations, including but not limited to:
    • Phase 3 development activities
    • Health authority meetings related to drug development and marketing applications
  • Lead and/or support strategy and execution: amendments/supplements and other policies and procedures as assigned
  • Work with Regulatory Affairs leadership to review and approve promotional and non-promotional materials.
  • Conduct frequent Regulatory Intelligence related to the assigned programs and disseminate relevant information to Sr. Management and cross-functional teams.
  • When applicable, mentor and direct junior-level regulatory personnel, who may or may not report directly to the incumbent.
  • Manage other regulatory activities as assigned, which may involve nonclinical studies and strategies, and commercial activities.

 

Qualifications:

  • Advanced degree such as PharmD, MD, or PhD preferred
  • 8-10 years of Regulatory Affairs experience in the biopharmaceutical industry
  • Rare Disease experience is required; late-stage development experience for rare diseases is preferable
  • Experience with successful US and EU submissions in rare disease
  • Experience leading, preparing, and submitting successful submissions, preferably NDAs and MAAs.
  • Ability to analyze and interpret scientific data and regulations to apply to a rare disease program
  • Evidence of being a critical strategic thinker who is solution-oriented with the ability to think outside of the box.
  • Ability to prioritize multiple urgent priorities and experience with wearing multiple hats; management also of non-regulatory functional activities is preferred
  • Thorough understanding and demonstrated experience with eCTD submission requirements, utilizing document templates, and knowledge of global operational regulations and guidelines
  • Excellent written and oral communication skills
  • Must be a collaborative team player who is comfortable wearing many hats in a small biotech environment.

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