Regulatory Affairs-CMC Strategist (Small Molecules)

Role Overview:

• Provide senior strategic Regulatory CMC leadership across Antares’ portfolio, ensuring cohesive, phase-appropriate global strategies for early-stage development.
• Advise on CMC readiness for INDs and global CTAs, ensuring alignment with clinical development plans and corporate objectives.
• Guide the integration of CMC regulatory considerations into early development, manufacturing, and supply decisions.

Responsibilities:

• Apply regulatory precedent, experience, and intelligence to anticipate challenges and enhance probability of regulatory success.
• Provide strategic regulatory guidance on process and analytical development.
• Monitor and interpret global CMC regulatory requirements and emerging trends, advising leadership on potential impact to development and registration strategy.

Qualifications:

• Advanced degree (PhD, PharmD, or equivalent) in Chemistry, Pharmacy, Chemical Engineering, or related discipline.
• 10+ years of Regulatory Affairs experience with significant focus on Regulatory CMC.
• Demonstrated senior-level experience developing global Regulatory CMC strategies for small molecule programs.