Job Details

Overview

Join to apply for the Senior Director, Regulatory CMC role at IDEAYA Biosciences.

Location: South San Francisco. This position is onsite four days per week per company policy.

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 role defines the CMC regulatory strategy in partnership with main stakeholders and manages processes required to plan and execute CMC regulatory strategies. You will work closely with pharmaceutical development colleagues and be responsible for the Module 3 (Quality) of INDs and Marketing Authorization Dossiers for the IDEAYA portfolio. The role provides leadership at the product level to ensure first-pass global approvals of CMC regulatory submissions. You will also lead the interpretation and implementation of CMC regulatory guidelines and regulations to assure approvability in high-priority regions. The role reports to the 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 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.
• Be a 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 submissions (IND/IMPD/CTA), 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, review, and commentary on technically complex CMC documentation for submission to regulatory authorities, including process development, process validation, comparability studies, analytical method development and validation, and establishment of specifications with in-process, release, and stability data including expiry dating and phase-appropriate information.
• 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.

Requirements

• Bachelor's degree in a Life Sciences discipline or equivalent; advanced degree (MS/PhD/PharmD) preferred.
• Minimum of ten (10) years of experience in clinical regulatory with leadership potential; oncology experience preferred.
• Proven ability to develop and manage a high-performance regulatory CMC team focused on accountability and delivering results.
• Excellent track record for oncology product approvals in the US and EU preferred.
• Thorough understanding of the drug development process, regulatory requirements, guidance, accelerated regulatory review paths, and policy trends.
• Demonstrated knowledge of eCTD elements, structure and content; expertise in Module 3.
• Direct, hands-on experience in the preparation and oversight of CMC submissions (INDs, IMPDs, NDAs and/or MAAs).
• Experience with participation in global Health Authority interactions including leading FDA CMC development review meetings.
• Experience collaborating with CDMOs, contractors, and partners is a plus.
• Balance of strategic thinking and strong analytical skills with the ability to execute.
• Experience with international regulatory submissions and understanding of worldwide guidelines and regulations preferred.

Essential Skills And Abilities

• Outstanding interpersonal and communication skills with ability to work with cross-functional teams (discovery, CMC, quality, regulatory and development).
• Demonstrated excellence in regulatory liaison/strategy and effective negotiations with regulatory authorities.
• Strategic thinking, leadership, assertiveness, strong technical background, and project management skills demonstrated on drug development teams.
• Ability to analyze worldwide regulatory requirements to synthesize a global regulatory development strategy.
• Excellent written and verbal communication skills, with ability to prepare complex documents/submissions and give presentations.
• Ability to work independently.

Total Rewards

IDEAYA offers a competitive total rewards package reflecting our pay-for-performance philosophy, including potential merit-based salary increases, discretionary annual incentive, and discretionary stock option awards (board approval required). Benefits include medical/dental/vision coverage (100% company paid for employees and 90% for dependents), 401k, ESPP, and wellness programs.

The expected salary range for the role of Senior Director of Regulatory CMC is $238,000-$294,000. Final salary depends on location, experience, disease areas, education, and interview performance.

The Company complies with equal employment opportunity laws and does not discriminate based on protected characteristics. This position requires onsite work in IDEAYA facilities with potential work-from-home flexibility, and all employees must be fully vaccinated for COVID-19, subject to applicable law and reasonable accommodations.

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

Seniority level

• Director

Employment type

• Full-time

Job function

• Legal

Industries

• Internet News