Associate Director, Regulatory Affairs CMC

Role Summary

Associate Director, Regulatory Affairs CMC, reporting to the Senior Director, Regulatory Affairs CMC, responsible for developing and executing CMC regulatory strategies for Olema products in development and post-approval. Ensure strategies align with Health Authority requirements globally and provide guidance for high-quality, on-time CMC sections of regulatory submissions, plus cross-functional support.

Responsibilities

• Provide CMC regulatory expertise for global development and registration programs (e.g., INDs, CTAs, BLAs and MAAs)
• Support regulatory agency interactions to align on CMC strategies for initial INDs/CTAs, marketing registration applications, supplements and variations
• Provide CMC support on the global regulatory plan, development plans/clinical study designs and risk assessments
• Proactive and effective communication of critical issues and potential mitigations with teams, senior management and key stakeholders in a timely manner
• Assess and communicate regulatory requirements to ensure all development activities are in compliance with applicable regulations and guidelines
• Manage and ensure compliance with all reporting requirements, including annual and periodic reports
• Collaborates with internal and external teams (CMC, QA, Supply Chain, RA, etc.)
• Assist with planning, compilation, review, approval and submission of high-quality CMC-related sections of regulatory submissions, including responses to questions from various regulatory authorities, working with partners across Research, Process Sciences, Manufacturing, QC/QA, Global Supply Chain and other business partners
• Provide regulatory support for relevant quality systems such as change control, discrepancy management, and inspection management. Assess proposed manufacturing process changes and provide strategic regulatory guidance to enable global implementation
• Support interactions with regulatory agencies during inspections
• Maintain up-to-date knowledge of FDA/EMA regulations, ICH guidelines and other international regulatory guidelines as needed to support global programs

Qualifications

• Bachelor's degree required, preferably in a scientific field; advanced degree is a plus
• Excellent knowledge of current CMC regulations and regulatory procedures
• Excellent working knowledge of international regulatory requirements and environment, including an understanding of GXP
• Deep understanding of clinical trial requirements for initial INDs/CTAs for all development phases early to late-stage
• Minimum 8 years of experience in clinical research, biotech, and/or pharmaceutical company, with minimum 6 years of Regulatory Affairs experience within clinical research or pharmaceutical
• Experience in small molecule drug development; oncology experience is a plus
• Global CMC regulatory experience for clinical trials is required
• Post-approval (commercial) experience is a plus
• Experience with eCTD requirements and electronic submissions
• Experience with international regulatory submissions and processes is a strong plus

Skills

• Strong business acumen and ability to work with international and cross-functional partners
• Strategic thinking with creativity and effectiveness in addressing major strategic challenges and balancing short-term needs with long-term vision
• Proven ability to deliver on goals within a cross-functional team environment with professionalism
• Excellent verbal, written and presentation skills
• Ability to analyze and convey difficult and complex issues clearly to internal and external stakeholders
• Fosters open communication, listens and facilitates discussion
• Learner mindset with adaptability to a changing environment
• Ability to prioritize and manage multiple tasks and requests efficiently

Education

• Bachelor's degree required; advanced degree preferred

Additional Requirements

• Role is based in San Francisco, CA with 10% travel