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IDEAYA Biosciences · 2 weeks ago

Senior Director, Regulatory CMC

South San Francisco, CA

Full-time

Onsite

Director/Executive

$238K/yr - $294K/yr

10+ years exp

IDEAYA Biosciences is a precision medicine oncology company committed to the discovery and development of transformative therapies for cancer. The Senior Director, Regulatory Affairs CMC will lead the CMC regulatory strategies for therapeutic development programs, ensuring first pass global approvals of CMC regulatory submissions and collaborating closely with pharmaceutical development colleagues.

BiotechnologyHealth CareOncologyTherapeutics

Responsibilities

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

Leads 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 partners with Technical Operations, Manufacturing, and Quality counterparts on processes and program prioritization; Ensures cross-functional alignment on regulatory plans and strategies

Effectively manage regulatory CMC aspects of the preparation and submission of CMC sections of eCTD s 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

Facilitates the development of, reviews, 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 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

Articulates complex CMC regulatory issues to project teams and external stakeholders to support global development and commercialization of drug candidates

Qualification

Regulatory CMC leadershipOncology experienceECTD submissionsDrug development processModule 3 expertiseGlobal regulatory strategyInterpersonal skillsAnalytical skillsProject managementCommunication skills

Required

Bachelor's degree in a Life Sciences discipline or equivalent, with advanced degree (MS/PhD/PharmD) preferred

Minimum of ten (10) years of experience in clinical regulatory and high potential for leadership roles

Proven ability to develop and manage a high-performance regulatory CMC team focused on accountability and meeting and exceeding expectations

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

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

Prior 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

Balance of strategic thinking and strong analytical skills with ability to execute

Outstanding interpersonal and communication skills with demonstrated ability to work with cross functional teams comprised of discovery, CMC, quality, regulatory and development teams

Demonstrated excellence in regulatory liaison/strategy & effective negotiations with regulatory authorities

Strategic thinking, leadership skills, assertiveness, strong technical background, and project management skills as evidenced by past performance on drug development project teams

Able to analyze worldwide regulatory requirements to synthesize a global regulatory development strategy as evidenced by past regulatory experience

Excellent interpersonal skills

Excellent communication skills (verbal and written) as evidenced by a demonstrated ability to prepare complex documents / submissions and to give presentations

Ability to work independently