Senior Director, Regulatory CMC

Non-Solicitation Policy and Notice to Agencies and Recruiters
IDEAYA’s Non-Solicitation Policy strictly prohibits agencies and recruiters from any contact or communication with IDEAYA employees, managers, and leaders to submit unsolicited candidate resumes and/or to solicit business partnerships.

Submission of unsolicited candidate resumes by agencies or recruiters, with or without a contract in place with IDEAYA Biosciences Inc., will not create any implied obligation. Failure to comply with this policy will result in disqualification from current and future business opportunities with IDEAYA Biosciences.

All recruiting and talent agency decisions are strictly managed by the internal IDEAYA Human Resources function. All communication by external agencies and recruiters must be directed to [email protected]
. We ask that you only email your interest once.

Job Summary

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. This allows us 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 (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.

When you’re at IDEAYA, you will be in the midst of brilliant minds working on precision medicine therapies to help cancer patients. We are passionate and committed to being at the forefront of oncology medicine. We are inquisitive, ask deep questions, and are data-driven innovators who like to collaborate and use teamwork to move science forward.

For more information, please visit: www.ideayabio.com

Location: South San Francisco

Position Summary
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.

Manage processes required to plan and execute CMC regulatory strategies.

Work in close collaboration with pharmaceutical development colleagues.

Be responsible for Module 3 (Quality) of IDEAYA’s INDs and Marketing Authorization Dossiers.

Provide leadership at a product level, ensuring first-pass global approvals of CMC regulatory submissions.

Lead the interpretation and implementation of CMC regulatory guidelines, regulations, and current environment to assure approvability in high-priority regions.

This role reports directly to the Vice President of Regulatory Affairs. The position is based in our South San Francisco headquarters and requires being onsite four days per week per company policy.

Job Description

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, overseeing submission and approval processes in close partnership with CMC and Regulatory Affairs teams.

Prepare CMC documents in response to Health Authority or Agency requests for information.

Collaborate cross-functionally with teams to generate CMC regulatory documents, including review and resolution of comments.

Serve as a member of program-specific regulatory teams.

Partner with Technical Operations, Manufacturing, and Quality counterparts on processes and program prioritization, ensuring cross-functional alignment on regulatory plans and strategies.

Manage regulatory CMC aspects of preparation and submission of CMC sections of eCTD supporting applications (IND/IMPD/CTA submissions), annual reports, and marketing applications.

Interpret and implement ICH guidelines with a goal of approved/harmonized regulatory control strategy.

Facilitate the development, review, and comments 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.

Anticipate risks and lead internal discussions to find innovative solutions, 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 commercialization of drug candidates.

Requirements:

Bachelor’s degree in Life Sciences or equivalent; advanced degree (MS/PhD/PharmD) preferred.

Minimum of 10 years’ experience in clinical regulatory affairs with high leadership potential; oncology experience preferred.

Proven ability to develop and manage a high-performance regulatory CMC team.

Excellent track record for oncology product approvals in the US and EU preferred.

Thorough understanding of drug development process, pharmaceutical industry, healthcare environment, regulatory requirements, guidance, accelerated regulatory review paths, and policy trends.

Demonstrated knowledge of eCTD elements, structure, and content; expertise in Module 3.

Hands-on experience in preparation and oversight of CMC submissions (INDs, IMPDs, NDAs, and/or MAAs).

Experience participating in global Health Authority interactions, including leading FDA CMC development review meetings.

Experience collaborating with CDMOs, contractors, and partners is a plus.

Strategic thinking, analytical skills, and ability to execute.

Experience with international regulatory submissions and knowledge of worldwide guidelines and regulations preferred.

Essential Skills and Abilities:

Outstanding interpersonal and communication skills with demonstrated ability to work with cross-functional teams.

Excellence in regulatory liaison/strategy and effective negotiations with regulatory authorities.

Strong leadership, strategic thinking, technical knowledge, and project management skills.

Ability to analyze worldwide regulatory requirements and synthesize a global regulatory strategy.

Excellent verbal and written communication skills.

Ability to work independently.

Total Rewards
IDEAYA offers a competitive total rewards package, including:

Merit-based salary increases.

Company discretionary short-term incentive plan participation.

Company discretionary stock option awards (board approval required).

Comprehensive benefits including medical/dental/vision coverage (100% company-paid for employees, 90% for dependents), 401k, ESPP, and wellness programs.

Salary Range: $238,000–$294,000, dependent on location, experience, disease area expertise, education, and interview performance.

Equal Opportunity Statement:
IDEAYA complies with all laws respecting equal employment opportunities and does not discriminate against applicants based on any legally protected status. This role requires onsite work with work-from-home flexibility and full COVID-19 vaccination, subject to legal accommodations.

IDEAYA is an equal opportunity employer. EOE/AA/Vets.

Workplace Approach:
IDEAYA values onsite presence for effective collaboration. Our hybrid work model requires all staff to be onsite four days per week, with one day working from home.

Apply here