Associate Director, Regulatory Affairs CMC

Role Summary

Associate Director, Regulatory Affairs CMC, based in San Francisco, CA; responsible for developing and executing CMC regulatory strategies for Olema product(s) in development and post-approval, ensuring alignment with Health Authority requirements globally, and providing guidance for high quality and on-time CMC sections of regulatory submissions. Also provide CMC regulatory strategy support to cross-functional teams.

This role is based out of our San Francisco, CA office and will require 10% travel.

• Provide CMC regulatory expertise for global development and registration programs (e.g., INDs, CTAs, BLAs and MAAs)
• Support regulatory agency interactions to ensure alignment 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 well with internal and external teams (CMC, QA, Supply Chain, RA etc)
• Assist with the planning, compilation, review, approval and submission of high-quality CMC related sections of regulatory submissions, including responses to questions from various regulatory authorities, working in collaboration with partners in 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 and expertise with FDA/EMA regulations, ICH guidelines and other international regulatory regulations and guidelines, as needed to support global programs

• Required:
  
  Bachelor's degree is required, preferably in a scientific field; advanced degree is a plus
• Required:
  
  Excellent knowledge of current CMC regulations and regulatory procedures
• Required:
  
  Excellent working knowledge of international regulatory requirements and environment, including an understanding of GXP
• Required:
  
  Deep understanding of clinical trial requirements for initial INDs/CTAs for all development phases early to late-stage
• Required:
  
  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
• Required:
  
  Experience in small molecule drug development; oncology experience a plus
• Required:
  
  Global CMC regulatory experience for clinical trials
• Preferred:
  Post-approval (commercial) experience
• Required:
  
  Experience with eCTD requirements and electronic submissions
• Preferred:
  Experience with international regulatory submissions and processes
• Required:
  
  Strong business acumen and ability to work with international and cross-functional partners
• Required:
  
  Very strong strategic skills with ability to balance short-term needs and long-term vision
• Required:
  
  Proven ability to deliver on goals within a cross-functional team environment with professionalism
• Required:
  
  Excellent verbal, written and presentation skills
• Required:
  
  Ability to analyze and convey difficult and complex issues clearly to internal and external stakeholders
• Required:
  
  Foster open communication, listen and facilitate discussion
• Required:
  
  Maintain learner mindset and adapt to changing environment
• Required:
  
  Ability to prioritize and manage multiple tasks efficiently

• Communication and collaboration across cross-functional teams
• Strategic thinking and problem solving in regulatory contexts
• Regulatory intelligence and risk assessment
• Regulatory submissions planning and management
• Quality systems knowledge related to regulatory processes

• Bachelor's degree in a scientific field required; advanced degree a plus