Director – Regulatory CMC

Bristol Myers Squibb

. Responsible for working within the CMC team to develop and execute the CMC global regulatory strategy for RayzeBio radiopharmaceutical drugs, leading to successful preparation and approval of Investigational New Drug applications (INDs), Clinical Trial Applications (CTAs), Drug Master Files (DMFs), New Drug Applications (NDA), and Marketing Authorization Application (MAA) submissions.

Posted 5/2/2026full-timeRemote • California • 🇺🇸 United StatesLead💰 $210,572 - $255,164 per yearWebsite

About the role

Key responsibilities & impact

Responsible for working within the CMC team to develop and execute the CMC global regulatory strategy for RayzeBio radiopharmaceutical drugs, leading to successful preparation and approval of Investigational New Drug applications (INDs), Clinical Trial Applications (CTAs), Drug Master Files (DMFs), New Drug Applications (NDA), and Marketing Authorization Application (MAA) submissions.
Responsible for content development, compilation, maintenance, and review of the Quality Module for regulatory documentation (e.g., IND, IMPD, facility DMF, NDA, MAA, amendments and post approval supplements) for submission to global Health Authorities in compliance with departmental and regulatory standards
Prepare Health Authority responses & meeting/briefing packages
Participate/lead Health Authority meetings
Independently manage and prioritize multiple complex projects
Manage and maintain strong working relationships with the regulatory CMC team and cross functional teams, participate in and/or lead multifunctional teams
Lead the CMC regulatory function within cross functional teams for technology transfer to endure that deliverables align with regulatory strategy
Work with the CMC teams to critically and strategically review CMC activities and documentation (e.g., protocols, reports, specifications, analytical methods, batch records) that support development, process validation, and tech transfer activities, to meet regulatory standards
Support Manufacturing Change Controls for global impact and guide technical teams on global change management
Provide ad hoc Regulatory-CMC support to RayzeBio manufacturing team
Actively participate on Global Regulatory Team(s) to develop global submission plans that comply with local regulatory requirements
Actively participate with Global Regulatory Leads to develop content of container labels
Review and guide content of CMC information in nonclinical and clinical documents including clinical protocols, pharmacy manuals, investigator brochures, and prescribing information
Research and provide analysis of current US and international regulations and guidance, and activities for latest technological innovation and knowledge in radiochemistry, drug development, manufacture, testing, supply and allied functional areas in the field
Participate in trade groups and represent RayzeBio at scientific conferences and meetings
Communicate critical issues to Management

Requirements

What you’ll need

Bachelor’s degree in chemistry or related field is highly desire OR Master’s degree with 7 or more years of hands-on regulatory experience OR an advanced degree with 5 or more years of hands-on regulatory experience
Previous experience with radiopharmaceutical therapy(therapeutic and diagnostic), radiopharmaceutical cold kits, and/or PET drug products is required
Prior experience in independently authoring IND, IMPD, NDA, MAA and/or DMF CMC sections is required
Understanding phase-appropriate data requirements for regulatory filings is desired
Demonstrable record of strong leadership and teamwork in a cross-functional industry environment
Excellent written and verbal communication skills.

Benefits

Comp & perks

Health Coverage: Medical, pharmacy, dental, and vision care.
Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.

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Hard Skills & Tools

regulatory strategyInvestigational New Drug applicationsClinical Trial ApplicationsDrug Master FilesNew Drug ApplicationsMarketing Authorization ApplicationQuality Module developmentregulatory documentationCMC activitiesdata requirements for regulatory filings

Soft Skills

leadershipteamworkcommunicationproject managementrelationship managementstrategic reviewproblem-solvingindependenceprioritizationcollaboration

Certifications

Bachelor’s degree in chemistryMaster’s degreeadvanced degree