Associate Director, Regulatory Affairs CMC

Associate Director, Regulatory Affairs CMC

Reporting to the Senior Director, Regulatory Affairs CMC, the Associate Director, Regulatory Affairs CMC will develop and execute CMC regulatory strategies for Olema product(s) in development and post‑approval. The role ensures that strategies align with global Health Authority requirements, provides guidance for high‑quality, on‑time CMC sections of regulatory submissions, and supports cross‑functional teams throughout the process.

This position is based in San Francisco, CA and requires approximately 10% travel.

Your work will primarily encompass:

• Provide CMC regulatory expertise for global development and registration programmes (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
• Communicate 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
• Collaborate with internal and external teams (CMC, QA, Supply Chain, RA, etc.)
• Assist with planning, compilation, review, approval and submission of high‑quality CMC sections of regulatory submissions, including responses to questions from regulatory authorities, working 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, and assess proposed manufacturing process changes 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 programmes

Ideal Candidate Profile

A love of challenging, important work. The team is pragmatic, driven to imagine and develop meaningful therapies for improving lives. All employees play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. We seek someone with the right combination of knowledge, experience, and attributes for this role.

Knowledge

• Bachelor’s degree is required, preferably in a scientific field; an advanced degree is a plus
• Excellent knowledge of current CMC regulations and regulatory procedures
• Excellent working knowledge of international regulatory requirements and environments, including an understanding of GXP
• Deep understanding of clinical trial requirements for initial INDs/CTAs for all development phases from early to late stage

Experience

• Minimum 8 years of experience in clinical research, biotech, and/or pharmaceutical companies, with at least 6 years of Regulatory Affairs experience within clinical research or pharmaceutical contexts
• Experience in small‑molecule drug development is required; oncology therapeutic area 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

Attributes

• Strong business acumen and ability to work successfully with international and cross‑functional partners
• Very strong strategic skills, including creativity and effectiveness in identifying and addressing major strategic challenges, balancing short‑term needs with long‑term vision
• Proven ability to deliver on goals within a cross‑functional team/partnership environment with high professionalism
• Excellent verbal, written and presentation skills
• Ability to analyze, define and effectively convey difficult and complex issues to internal and external stakeholders
• Fosters open communication, listens and facilitates discussion
• Maintains a learner mindset, adapting to an ever‑changing environment
• Proven ability to prioritize and manage multiple tasks and requests efficiently

Compensation

The base pay range is $190,000 – $220,000 annually; total compensation includes equity, bonus and benefits.

EEO Statement

We provide equal opportunity to all employees and applicants for employment.

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