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

This role provides strategic, tactical, and operational regulatory CMC leadership across advanced therapeutic modalities and manufacturing technologies to accelerate development of the synthetic peptides and oligonucleotide portfolio, supporting clinical trial applications, market registrations, and post-approval submissions.

Key Responsibilities
- Deep technical knowledge of synthetic peptide and oligonucleotide CMC drug development and manufacturing sciences (drug substance, drug product, analytical sciences such as solid-phase synthesis, purification, conjugation, characterization, and control strategies).
- Knowledge of global CMC regulatory requirements and guidelines for synthetic peptides and oligonucleotides for clinical development, global registrations, and lifecycle management.
- Develop and implement innovative regulatory strategies and platform-based approaches incorporating evolving external expectations.
- Provide regulatory guidance to CMC development teams for development and lifecycle planning.
- Lead preparation, critical review, and approval of CMC documentation for global submissions and responses (clinical trial applications, marketing applications, variations/supplements, and health authority queries).
- Lead critical review of molecule-specific CMC development and lifecycle strategies, including impurity profiles, sequence variants, delivery systems, and stability.
- Provide timely, clear regulatory advice; make decisions on CMC regulatory strategies impacting global submissions.

Basic Qualifications/Requirements
- B.S. in a science/engineering/STEM field (advanced degree preferred, e.g., Chemistry, Pharmaceutics, Chemical Engineering, Analytical Sciences, Biochemistry, Molecular Biology).
- 10+ years of Regulatory CMC or technical CMC experience supporting clinical development and/or commercialization of synthetic peptides/oligonucleotides (advanced modalities experience encouraged).

Additional Skills/Preferences
- Experience authoring peptide/oligonucleotide CMC submissions and responding to regulatory questions.
- Knowledge of major global regulatory procedures and evolving expectations for complex modalities/platform technologies.
- Experience in peptide/oligonucleotide drug substance/product development and manufacturing.
- Understanding of key development considerations (synthesis scalability, impurity control, analytical characterization, stability, delivery systems).
- Experience managing complex submission strategies; plan for and participate in Health Authority interactions.
- Strong risk assessment, communication, leadership/influencing, attention to detail, quality commitment, and cross-functional collaboration.