About company:
A pre-IPO biotech
Key Responsibilities:
1) Regulatory CMC Strategy: Develop and execute comprehensive, proactive global CMC regulatory strategies for assigned programs from early development through marketing application and post-approval.Ensure strategies are aligned with regulatory requirements (FDA, EMA, PMDA, NMPA, etc.), corporate goals, and scientific development plans.
2) Regulatory Submission Leadership: Serve as the Regulatory CMC Lead for major filings. Author, review, and critically assess high-quality CMC sections for all global regulatory submissions (e.g., INDs, NDAs, variations, supplements). Ensure content is scientifically rigorous, compliant with regulations.
3) Health Authority Interactions: Lead the preparation, coordination, and execution of all CMC-focused interactions with global health authorities. This includes managing briefing book preparation, coordinating internal rehearsals, serving as the primary CMC spokesperson in meetings, and ensuring clear, consistent messaging. Draft and finalize official responses to CMC-related questions.
4) Expert Guidance on Complex Products: Act as the in-house subject matter expert on global regulatory CMC requirements for complex oligonucleotide-based products, including device-drug combination products (e.g., auto-injector). Interpret evolving regulations and guidance to provide clear, actionable direction to the CMC team.
5) Strategic Liaison & Collaboration: Serve as the primary regulatory liaison between the CMC department and the broader Regulatory Affairs team. Foster strong, collaborative relationships ensure integrated global regulatory strategies. Proactively communicate regulatory risks, opportunities, and requirements to CMC and project leadership.
Qualifications & Experience:
Education:
Advanced degree (Ph.D. preferred, M.S. required) in Chemistry, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, or a related field.
Experience: Minimum of 10 years of combined experience in CMC development (process, analytical, formulation) and Regulatory Affairs CMC within the pharmaceutical industry. Experience with device-drug combination products is a plus. Proven track record of successfully developing and implementing global CMC regulatory strategies from Phase 1 through approval. Extensive experience authoring CMC sections for major filings (IND/NDA) and leading health authority interactions (e.g., pre-IND, EOP, pre-NDA, advisory committee meetings).
Knowledge & Skills: Deep Regulatory Expertise: Comprehensive knowledge of US, EU, and ICH CMC guidelines.Strong Technical Foundation: Must understand the scientific and technical nuances of oligonucleotide synthesis, purification, analytics, and stability to critically evaluate data and defend strategies.
Exceptional Communication: Outstanding written and verbal communication skills in English are mandatory. Ability to distill complex technical information into clear, persuasive regulatory arguments for diverse audiences, including senior management and health authorities.
Strategic & Agile Thinker: Demonstrated ability to think strategically, anticipate regulatory challenges, and develop innovative solutions. Fast learner who thrives in a dynamic, science-driven environment.
Leadership & Influence: Strong leadership presence with the ability to influence and align cross-functional teams without direct authority. Excellent project management and organizational skills.
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