Job Description
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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