Director of Regulatory Strategy

OVERVIEW:

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Our client is researching autoimmune-related diseases. They just received positive results from a POC study assessing the safety and efficacy of their molecule and have had good data in other programs for over a year. They are looking to expand their 4 indications and need comprehensive regulatory strategies.

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SCOPE & RESPONSIBILITIES:

• Lead the development of Regulatory Plans for one specific indication globally.
• Interact with global health authorities and understand the larger picture of the timing of filings, meetings, etc.
• Be regulatory lead on the creation of briefing books.
• File CTAs and answer technical questions from agencies.
• The client is hiring multiple Directors of Strategy, each will own the planning and execution of one indication. All indications are autoimmune/immunology-based.

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SPECIAL REQUIREMENTS:

• Director level
• Flexible Mindset

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LOGISTICS:

• Initial interview with SVP of Global Regulatory Affairs. There could be additional conversations with team members after this.
• Fully remote within the United States
• Temp-to-perm (likely ~40 hours/week for 6 months of contract work before going permanent)