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.
Responsibilities
- 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
Qualifications
- 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
Skills
- 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
Education
- Bachelor's degree in a scientific field required; advanced degree a plus