REQUIRED QUALIFICATIONS

· Strong background in U.S. regulatory affairs.
· Direct experience interfacing with the FDA.
· Proven track record in Phase 2 through late-stage drug development.
· Experience leading and conducting meetings with regulatory agencies.
· Ability to work highly independently and proactively with minimal supervision.
· Bachelor’s degree or higher in a relevant scientific or regulatory field.

PREFERRED QUALIFICATIONS

· Regulatory experience in endocrinology, particularly with the FDA’s Endocrinology Division.
· Broader therapeutic experience is acceptable if it aligns with the required criteria.
Job Types: Part-time, Contract
Pay: $130.00 - $150.00 per hour
Expected hours: 5 – 10 per week

Experience:

• Direct experience interfacing with the FDA: 1 year (Preferred)
• Phase 2 through late-stage drug development: 1 year (Preferred)
• Endocrinology: 1 year (Preferred)

Work Location: Remot

KEY RESPONSIBILITIES

· Provide strategic regulatory input for the development of our product for chronic hypoparathyroidism, including Phase 2 through late-stage activities.
· Prepare FDA briefing books and support agency meeting preparations.
· Interface directly with the FDA, leading and conducting regulatory meetings as needed.
· Drive program progress independently, ensuring alignment with U.S. regulatory requirements.
· Offer expert guidance on regulatory strategies to support exploratory development efforts.