Regulatory Affairs-CMC Strategist (Small Molecules)

Role: Regulatory Affairs-CMC Strategist (Small Molecules) Location: Boston, MA or Remote (East Coast hours preferred) Type: Fractional/Part-time/Consultant Commitment: ~5–10 hours/week; increased support during key submissions Compensation: $300-$350/hr Job Summary: Antares Therapeutics is seeking an experienced Regulatory Affairs–CMC Strategist (Consultant) to provide senior strategic advisory leadership for global, phase-appropriate CMC regulatory strategies supporting early-stage small molecule product development. This fractional consultant role serves as a strategic partner to Global Regulatory Affairs, Technical Operations, Quality, Supply Chain, and Development teams, ensuring CMC strategies are regulator-ready, risk-based, and aligned with overall program and corporate objectives. The role emphasizes strategic guidance, regulatory judgment, and senior advisory leadership, rather than day-to-day execution. This role is crucial in ensuring that all CMC aspects of drug development meet global (US, EU, APAC, LA) regulatory requirements, supporting Antares Therapeutics' mission to bring transformative oncology therapies to patients. This role is:

• Strategic, advisory, and judgment-driven
• Focused on “what is sufficient, defensible, and approvable”
• A senior thought partner to Regulatory, CMC, and leadership teams

This role is not:

• A day-to-day CMC authoring or execution role
• A project management-heavy position
• A full-time operational Regulatory Affairs role

Key Responsibilities:

• 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.
• Apply regulatory precedent, experience, and intelligence to anticipate challenges and enhance probability of regulatory success.
• Provide strategic regulatory guidance on:
• Process and analytical development
• Control strategies
• Manufacturing changes and comparability
• Supply chain considerations
• Identify and communicate CMC-related regulatory risks, and advise on proactive mitigation strategies.
• Advise on de-risking CMC development strategies, assessing change controls and evaluate opportunities to accelerate development
• Collaborate cross functionally to assess the impact of proposed CMC changes and ensure applicable CMC changes are reported to health authorities in accordance with regulatory requirements
• Monitor and interpret global CMC regulatory requirements and emerging trends (US, EU, UK, APAC, Latin America), advising leadership on potential impact to development and registration strategy
• Serve as strategic CMC regulatory advisor for Health Authority interactions.
• Lead or advise on:
• CMC meeting strategy
• Briefing materials
• Regulatory positioning and messaging
• Provide strategic review of CMC sections for regulatory submissions as needed, including:
• INDs / CTAs
• CMC amendments and annual reports
• Serve as the regulatory representative at internal CMC team meetings
• Ensure regulatory CMC strategy remains aligned across functions and escalates issues that may impact development timelines or compliance.

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.
• Oncology and/or immunology therapeutic area experience is strongly preferred.
• Strong experience supporting early clinical development (IND/CTA) and lifecycle planning.
• Prior experience advising or leading CMC-related Health Authority interactions.
• Deep understanding of global CMC regulatory expectations (FDA, EMA, MHRA, ICH).
• Strong knowledge of small molecule CMC development, including solid dosage forms.
• Experience applying regulatory requirements pragmatically and phase-appropriately.
• Proven ability to operate as a senior strategic advisor in a consulting or fractional capacity.
• Strong regulatory judgment with the ability to influence decisions without direct authority.
• Excellent written, verbal, and presentation skills.
• Self-directed, able to operate independently in a fast-paced, evolving environment.

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