Senior Director, Regulatory CMC

Join to apply for the Senior Director, Regulatory CMC role at Bio Space

About IDEAYA Biosciences:
IDEAYA is a precision medicine oncology company committed to the discovery, development, and commercialization of transformative therapies for cancer. Our approach integrates expertise in small‑molecule drug discovery, structural biology and bioinformatics with robust internal capabilities in identifying and validating translational biomarkers to develop tailored, potentially first‑in‑class targeted therapies aligned to the genetic drivers of disease. We have built a deep pipeline of product candidates focused on synthetic lethality and antibody‑drug conjugates, or ADCs, for molecularly defined solid tumor indications.

Our mission is to bring forth the next wave of precision oncology therapies that are more selective, more effective, and deeply personalized with the goal of altering the course of disease and improving clinical outcomes for patients with cancer.

Location:

South San Francisco

IDEAYA Biosciences is seeking an experienced, motivated, outgoing leader to head Regulatory CMC. The Senior Director, Regulatory Affairs CMC will support the CMC Regulatory Affairs function and be responsible for planning and executing the CMC regulatory strategies for IDEAYA’s therapeutic development programs. This position will define the CMC regulatory strategy in partnership with main stakeholders and manage processes that are required to plan and execute CMC regulatory strategies.

You will be working in close collaboration with pharmaceutical development colleagues. You will be responsible for the Module 3 (Quality) of our INDs and Marketing Authorization Dossiers for IDEAYA portfolio. This position will provide leadership at a product level ensuring first pass global approvals of CMC regulatory submissions. Additionally, you will be accountable for leading the interpretation and implementation of CMC regulatory guidelines, regulations and current environment to assure approvability in high priority regions.

The role will report directly to Vice President of Regulatory Affairs.

This position is based in our South San Francisco headquarters and is required to be onsite four days per week per our company policy.

What you’ll do:

• Lead the Regulatory CMC function to support projects in development and the CMC portfolio goals.
• Lead the execution of global CMC regulatory plans, including overseeing the submission and approval process in close partnership with other functions in CMC and Regulatory Affairs.
• Lead the preparation of CMC documents in response to Health Authority or Agency requests for information.
• Manage processes: collaborate cross‑functionally with teams and departments to generate CMC regulatory documents including reviews and resolution of comments.
• Member of program specific regulatory teams.
• Proactively partner with Technical Operations, Manufacturing, and Quality counterparts on processes and program prioritization; ensure cross‑functional alignment on regulatory plans and strategies.
• Effectively manage regulatory CMC aspects of the preparation and submission of CMC sections of eCTD supporting applications (i.e. IND/IMPD/CTA submissions), annual reports and marketing applications.
• Exercise expertise in the interpretation and implementation of ICH guidelines with a goal of an approved/harmonized regulatory control strategy.
• Facilitate the development of, review, and comment on all technically complex CMC documentation for submission to regulatory authorities including process development, process validation, comparability studies, analytical method development, and analytical method validation supporting establishment of specifications and in‑process, release and stability data including expiry dating and information appropriate to phase of development.
• Anticipate risks and lead internal discussions to find innovative solutions for the identified risks, including assessment and communication of probabilities of technical and regulatory success.
• Articulate complex CMC regulatory issues to project teams and external stakeholders to support global development and…