Director, Global Regulatory Affairs – Chemistry, Manufacturing and Controls (CMC), Platform Innovation – Synthetic Peptides and Oligonucleotides

Key Responsibilities

• Deep technical knowledge of synthetic peptide and oligonucleotide CMC drug development and manufacturing sciences across modalities and platforms, including drug substance, drug product, and analytical sciences (e.g., solid-phase synthesis, purification, conjugation, characterization, and control strategies).
• Knowledge of global CMC regulatory requirements and guidelines for synthetic peptides and oligonucleotides to support clinical development, global product registrations, and lifecycle management of approved products.
• Development and implementation of innovative regulatory strategies and platform-based approaches, incorporating evolving external expectations (e.g., emerging guidance, novel modality considerations, and regulatory precedent).
• Provide regulatory guidance enabling CMC development teams to make well-informed decisions on development strategies and lifecycle planning.
• Lead preparation, critical review, and approval of CMC documentation for global regulatory submissions and responses, including clinical trial applications, marketing applications, variations/supplements, and responses to health authority queries.
• Take a proactive leadership role in the critical review of molecule-specific CMC development and lifecycle strategies, including considerations unique to peptides and oligonucleotides (e.g., impurity profiles, sequence-related variants, delivery systems, and stability).
• Provide high-quality, timely, and clear regulatory advice to support project teams in advancing complex modalities.
• Make decisions on CMC regulatory strategies impacting global submissions, ensuring alignment across geographies, teams, and platform approaches.

Basic Qualifications/Requirements

• B.S. degree in a science, engineering, or related STEM field (advanced degree preferred), such as Chemistry, Pharmaceutics, Chemical Engineering, Analytical Sciences, Biochemistry, Molecular Biology, or similar.
• 10+ years of Regulatory CMC or technical CMC experience supporting clinical development and/or commercialization of synthetic peptides, oligonucleotides, or related complex modalities. Candidates with broader experience in advanced modalities are encouraged to apply.

Additional Skills/Preferences

• Experience authoring CMC submission content for peptides and/or oligonucleotides, including participation in clinical trial and marketing authorization applications and responses to regulatory questions.
• Knowledge of major global regulatory procedures, regulations, and evolving expectations for complex modalities, including platform technologies.
• Relevant experience in peptide and/or oligonucleotide drug substance and/or drug product development, manufacturing, and commercialization.
• Demonstrated understanding of key development considerations for peptides and oligonucleotides (e.g., synthesis scalability, impurity control, analytical characterization, stability, and delivery systems such as conjugates or lipid-based formulations).
• Extensive regulatory experience managing complex submission strategies or equivalent combination of technical and regulatory expertise.
• Experience planning for and participating in Health Authority interactions.
• Demonstrated ability to assess and manage risk in a highly regulated and evolving modality space.
• Strong written, verbal, and presentation communication skills.
• Demonstrated leadership, with strong influencing and negotiation skills.
• High attention to detail and commitment to quality.
• Strong collaboration skills with ability to work effectively across diverse, cross-functional teams.