Associate Director, Regulatory Affairs CMC

Associate Director, Regulatory Affairs CMC

Olema Oncology is dedicated to developing better medicines for breast cancer and beyond. Our lead program, palazestrant (OP-1250), is a complete estrogen receptor antagonist (CERAN) currently in development for metastatic breast cancer with blockbuster potential as a monotherapy and in combination in ER+/HER2- metastatic breast cancer. Our follow-on product candidate, OP-3136, is a potent KAT6 inhibitor with best-in-class potential.

Our scientific breakthroughs are accelerated through the ways in which we fearlessly support, motivate, and challenge one another. At Olema, we know that when we put people first, our work becomes second to none. If you’re ready to join us at the edge of something unstoppable, let’s make a profound impact together for our patients, for your career, for what’s beyond
.

You can view our latest corporate deck and other presentations here.

As the Associate Director, Regulatory Affairs CMC, reporting to the Senior Director, Regulatory Affairs CMC, you will be responsible for developing and executing the CMC regulatory strategies for Olema product(s) in development and post-approval. You will ensure these strategies are aligned with Health Authority requirements globally and provide guidance and oversight for development of high quality and on-time CMC sections of the regulatory submissions.

In addition, you will provide CMC regulatory strategy support and guidance to cross-functional teams within the organization.

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

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

• Bachelor's degree is 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…