[Hiring] Director - Regulatory CMC @Bristol Myers Squibb

Role Description

We are seeking an experienced and motivated Director in Regulatory Affairs - CMC. This position will report to the Sr. Director of Regulatory Affairs-CMC and will oversee and/or manage CMC regulatory functions within RayzeBio. Responsibility expectations will be commensurate with experience.

• 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 ensure 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.

Qualifications

• Bachelor’s degree in chemistry or related field is highly desired 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.

Requirements

• Highly organized, with the ability to multi-task and handle pressure well.
• Meticulous with detail and precision.
• Ability to think through a project or task of diverse complexity and execute independently from beginning to end.
• Fully proficient in MS Office (Outlook, Word, PowerPoint, Excel, and Teams), Veeva Vault/RIM systems, and video conferencing.
• Strong communication and interpersonal skills.
• Should be assertive, proactive, professional, and confident.
• Excellent professional ethics and integrity.
• Flexibility to adapt in a cross-functional and dynamic start-up environment.

Benefits

• 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
  • Flexible time off (unlimited, with manager approval, 11 paid national holidays)
  • 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays.
  • Additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, and leaves of absence for various needs.