[Hiring] Regulatory Affairs-CMC Strategist @Antares Therapeutics
Role Description
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.
• Ensures CMC strategies are regulator-ready, risk-based, and aligned with overall program and corporate objectives.
• Emphasizes strategic guidance, regulatory judgment, and senior advisory leadership, rather than day-to-day execution.
• Crucial in ensuring that all CMC aspects of drug development meet global (US, EU, APAC, LA) regulatory requirements.
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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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.
• Ensures CMC strategies are regulator-ready, risk-based, and aligned with overall program and corporate objectives.
• Emphasizes strategic guidance, regulatory judgment, and senior advisory leadership, rather than day-to-day execution.
• Crucial in ensuring that all CMC aspects of drug development meet global (US, EU, APAC, LA) regulatory requirements.
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.
Apply tot his job
Apply To this Job