Associate Director, Regulatory CMC

Summary

A hands-on role providing both strategic and operational activities. This role develops and executes multi-product global regulatory CMC strategies for investigational products and leads the preparation and filing of regulatory CMC submissions. Manages interactions with Health Authorities for CMC topics. Provides regulatory CMC guidance to various cross-functional teams and ensures all applicable global regulatory requirements are considered and incorporated into product development.

Essential Functions

• Leads the preparation and review of CMC sections of global regulatory submissions, as well as the interactions and responses with regulatory agencies
• Member of technical development teams which require experienced interpretation of applicable EMA/FDA/ICH/Global regulations to ensure CMC compliance
• Defines CMC content (data and documentation) requirements for regulatory submissions and compiles/reviews this content for conformance with established requirements
• Provides CMC regulatory guidance to cross-functional teams and key stakeholders
• Manages regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP investigations throughout development
• Led projects with cross-functional teams and acts as the primary regulatory CMC contact for assigned products and projects
• Represents company in Health Authority meetings and leads or supports CMC preparation activities for meetings with Health Authorities on CMC related matters
• Stays abreast of current and evolving regulatory CMC requirements, applies this knowledge to assigned projects, and shares knowledge and experience with others to support their development
• Participates in the design, development and implementation of department strategies, providing recommendations in area of expertise

Requirements

• Bachelor’s Degree in a scientific discipline (e.g. Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices).
• Minimum 10 years of experience working in vaccine or biotech industry, or in a related field, or the equivalent combination of education and experience.
• Prior experience preparing/authoring CMC DS sections: BLA highly preferred. Post-approval supplements/variations highly preferred. INDs/IMPDs. Prior development or manufacturing experience is a plus.
• Computer software skills (LIMS, SAP, TrackWise, Veeva will be used).
• Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency.
• Excellent interpersonal skills to communicate difficult concepts.
• Strategic thinking and strong problem-solving skills.
• Collaborates and communicates in an open, clear, complete, timely, and consistent manner.
• Strong sense of planning and prioritization, and the ability to work with all levels of management.
• Advanced knowledge in regulatory (FDA, EMA, Health Canada and ICH) guidelines.

Qualifications

• None provided in the job posting.

Skills

• Knowledge of regulatory guidelines (FDA, EMA, Health Canada and ICH)
• Experience in vaccine or biotech industry
• Experience in preparing/authoring CMC DS sections
• Experience in managing regulatory assessments and guidance on product compliance topics
• Experience in leading cross-functional teams
• Experience in representing company in Health Authority meetings
• Experience in staying abreast of current and evolving regulatory CMC requirements
• Experience in participating in the design, development and implementation of department strategies

Benefits

Comprehensive benefits and an equity component.

Pay

Salary Range: $180,000 - $210,500 (SF Bay Area). Salary ranges for non-California locations may vary.

Schedule

Remote Work Arrangement (may be adjusted based on business needs, job responsibilities, or changes to company policy): Remote