Description

Our client is seeking an Associate Director or Director of Regulatory Affairs CMC. This position will report to the VP of Regulatory Affairs and will be responsible for providing the CMC and regulatory expertise necessary to lead the development, implementation, and influence of CMC regulatory strategy for New Chemical/Molecular Entity (NCE/NME), small molecule drugs, including... global submission strategy for investigational applications, clinical trial support, marketing application strategy, and CMC change management. **The expectation is to be onsite at our South San Francisco, CA office at least three days per week.**

Key Responsibilities include:
• Oversee and direct all regulatory CMC strategies in compliance with global regulatory requirements for the development of our products.
• Provide CMC regulatory support for new and ongoing clinical trials (e.g., clinical trial applications and import licenses, provide input for clinical protocols, labels, and other study-related materials).
• Work collaboratively with Pharmaceutical Development, Drug Substance, and GMP Quality Assurance, in addition to Project Management, Clinical Operations, Clinical Supply, and Regulatory Operations.
• 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.
• Provide hands-on support in the generation of CMC documents (e.g., Module 2 and Module 3 of eCTD, IMPD, etc.).
• Provide support for cGMP activities as they relate to regulatory affairs (e.g., regulatory impact assessments for change management, and regulatory inspection support).
• Drive a culture of continuous improvement to ensure compliance with Kezar standards, procedures, regulatory requirements, and expectations.
• Lead responses to CMC-related queries from health authorities.
• Lead preparation for CMC-related meetings with regulatory agencies.

You are encouraged to apply even if you do not meet each of the listed preferred qualifications.

Preferred Qualifications Include:
• BA/BS, MS, or Ph.D. in a relevant technical discipline or equivalent qualifications and experience.
• 10+ years of highly relevant pharmaceutical/biotechnology experience with strong CMC background. Candidates at the Director level would be expected to have significant years of additional experience.
• Excellent CMC technical writing and communications skills with a strong background in small molecules, ideally sterile parenteral and solid-oral dose formulations, manufacturing, and regulatory writing.
• 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.
• Experience with lyophilized products and injectable drug-device combination products preferred.
• Demonstrated success driving drug product development and managing all aspects of CMC documentation.
• Excellent working knowledge and understanding of applicable global regulations required – cGMP, global regulatory guidances, and compendial requirements, including FDA, EMA, ICH, WHO, USP-NF.
• Prior experience as the primary author of CMC sections of M2 and M3 of IND and 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 (e.g., Veeva Vault, StartingPoint templates, etc.).
• Excellent attention to detail, and strong computer and organizational skills are required.
• Must be a strong team player who is fully engaged, hands-on professional capable of working collaboratively and independently, with excellent verbal and written communication skills.
• Must have a quality mindset and deliver results in an ethical and positive manner.
• Flexibility and ability to work in a fast-paced, dynamic environment with limited supervision.
• Proven ability to manage multiple tasks and associated deadlines
South San Francisco CA USA

Salary Criteria