Job description
POSITION SUMMARY
Guide the overall CMC regulatory strategy globally and manage the required resources to meet an aggressive regulatory submission schedule, ensuring the effective fulfillment of company goals and objectives. This will be an individual contributor role reporting to Sr. VP, Regulatory Affairs and Quality. This role is preferably based in South San Francisco, however, remote working will be considered for the right candidate. For local candidates, this is a hybrid role that will require 3 days in the office (2 core days, 1 flex day).
ESSENTIAL DUTIES AND RESPONSIBILITIES
REQUIREMENTS
Education
Guide the overall CMC regulatory strategy globally and manage the required resources to meet an aggressive regulatory submission schedule, ensuring the effective fulfillment of company goals and objectives. This will be an individual contributor role reporting to Sr. VP, Regulatory Affairs and Quality. This role is preferably based in South San Francisco, however, remote working will be considered for the right candidate. For local candidates, this is a hybrid role that will require 3 days in the office (2 core days, 1 flex day).
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Direct successful preparation and approval of Investigational New Drug applications (INDs), Clinical Trial Applications (CTAs), New Drug Application (NDA), Marketing Authorization Application (MAA), and other CMC regulatory submissions
- Develop, compile, maintain, and review drug substance and drug product Quality Modules for submissions to U.S. and non-U.S. Health Authorities in compliance with regulatory requirements, ICH guidelines, and industry standards
- Take a leading role in meetings with Health Authorities. Prepare information packages and query responses
- Participate in and/or lead cross-functional teams
- Independently manage and prioritize multiple complex projects and work responsibilities
- Maintain cooperative and success-driven relationships with Clinical, Quality, and other departments within Structure. Interact productively with CMOs, consultants, and other stakeholders
- Effectively supervise, manage, and direct the activities of employees in your group
- Work with various CMC teams and individuals to ensure that CMC documentation (e.g., protocols, reports, specifications, analytical methods, batch records) meets regulatory requirements and effectively supports product development, process validation, tech transfer, and registration activities · Research and provide analysis of current US and international CMC regulations and guidance
- Actively participate on Global Regulatory Team(s) to develop global submission plans that comply with local regulatory requirements
- Actively participate with Global Regulatory Leads to develop content of container labels
- Review and guide content of CMC information in nonclinical and clinical documents, including clinical protocols, pharmacy manuals, investigator brochures, and prescribing information · Communicate critical issues to senior Management
REQUIREMENTS
Education
- Advanced degree (Ph.D., Pharm.D., or equivalent) in a relevant scientific discipline (e.g., Chemistry, Pharmacy, Chemical Engineering)
- Minimum of 10 -12+ years of experience in global regulatory affairs, with a focus on CMC, in the pharmaceutical or biotechnology industry
- Extensive prior experience in independently authoring IND, IMPD, NDA, MAA CMC sections
- Thorough understanding of phase-appropriate data requirements for regulatory filings
- Demonstrated record of strong leadership and teamwork in cross-functional industry environments
- Excellent written and verbal communication skills
- Highly organized, with the ability to multi-task and handle pressure well
- Meticulous attention to detail
- Ability to think through a project or task of diverse complexity and execute independently from beginning to end