Title: Senior Director/ Executive Director, CMC Regulatory Affairs

Location: Hybrid, 2 days onsite in San Francisco or San Diego

SciPro is currently engaged with an oncology biotech that's based in San Francisco and in San Diego. Working alongside the SVP, Regulatory Affairs, we are searching for a Senior Director/Executive Director, CMC Regulatory Affairs, to lead CMC regulatory activities and support all mid-stage clinical development programs. The role involves close collaboration with cross-functional teams including regulatory affairs, regulatory operations, quality, CMC, nonclinical, and clinical departments.

RESPONSIBILITIES

• Oversee and direct all CMC regulatory strategies in compliance with global regulatory requirements for the development products.
• Provide CMC regulatory support for new and ongoing clinical trials, e.g., manage/prepare CMC document packages in support of INDs, CTAs and amendments to global regulatory agencies (RAs) and health authorities (HAs)
• Work collaboratively with Pharmaceutical Development, Drug Substance, and GMP Quality Assurance, in addition to Project Management, Clinical Operations, Clinical Supply, and Regulatory Operations.
• Lead preparation and responses for CMC-related meetings with global RAs and HAs, balancing regulatory requirements and corporate objectives.
• Maintain current awareness of relevant global CMC requirements and identify and assess global regulatory risks and mitigation plans.
• Planning, oversight, and management of all CMC aspects of regulatory submissions, including strategy for updating existing dossiers, submission of new INDs/CTAs/NDAs/MAAs , etc.
• Evaluate proposed manufacturing changes for global impact to ongoing and existing filings and pvide strategic regulatory guidance for optimal implementation of changes. 
• Provide hands-on support in the generation of CMC documents (e.g., Module 2 and Module 3 of eCTD, IMPD, etc.).

QUALIFICATIONS

• BA/BS, MS, or Ph.D. in a relevant technical discipline or equivalent qualifications and experience.
• At least 10+ years of highly relevant pharmaceutical/biotechnology experience with strong CMC background. 
• Excellent CMC technical writing and communications skills with a strong background in small molecules, ideally solid-oral dose formulations, manufacturing, and regulatory writing.
• Prior experience as primary author of CMC sections of M2 and M3 of IND,NDA, and IMPD.
• Experience in addressing CMC-related regulatory queries from global health authorities.
• Experience with all phases of pharmaceutical development and related implementation of phase-appropriate regulatory CMC requirements and strategies.
• Demonstrated success driving drug product development and managing all aspects of CMC documentation.
• Prior experience as primary author of CMC sections of M2 and M3 of IND,NDA, and IMPD.
• Fluency with eCTD structure, differences in regional dossier requirements, and software tools commonly used to author, review, format, and approve submission documents.
• Must be a strong team player who is fully engaged, hands-on professional capable of working