[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. Apply tot his job Apply To this Job