Director – Regulatory CMC

📋 Description

• Accountable for collaborating within the CMC team to formulate and implement the global regulatory strategy for RayzeBio's radiopharmaceutical products, ensuring 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 the development, compilation, upkeep, and evaluation of the Quality Module for regulatory documentation (e.g., IND, IMPD, facility DMF, NDA, MAA, amendments, and post-approval supplements) to be submitted to global Health Authorities, adhering to departmental and regulatory standards.

• Prepare responses for Health Authority inquiries and organize meeting/briefing packages.

• Participate in or lead meetings with Health Authorities.

• Effectively manage and prioritize numerous complex projects independently.

• Cultivate and sustain strong collaborative relationships with the regulatory CMC team and cross-functional teams, participating in and/or leading multifunctional groups.

• Oversee the CMC regulatory function within cross-functional teams for technology transfer to ensure that deliverables align with the regulatory strategy.

• Collaborate with CMC teams to critically and strategically assess CMC activities and documentation (e.g., protocols, reports, specifications, analytical methods, batch records) that aid in development, process validation, and technology transfer activities, ensuring compliance with regulatory standards.

• Support Manufacturing Change Controls with a global scope and guide technical teams on global change management procedures.

• Provide ad hoc Regulatory-CMC assistance to the RayzeBio manufacturing team.

• Actively engage with Global Regulatory Team(s) to devise global submission strategies that comply with local regulatory requirements.

• Collaborate with Global Regulatory Leads to develop content for container labels.

• Review and advise on the CMC information contained in nonclinical and clinical documents, including clinical protocols, pharmacy manuals, investigator brochures, and prescribing information.

• Research and analyze current US and international regulations and guidance, as well as activities surrounding the latest technological innovations and knowledge in radiochemistry, drug development, manufacture, testing, supply, and related functional areas.

• Participate in trade groups and represent RayzeBio at scientific conferences and meetings.

• Communicate critical issues to Management.

⛳️ Requirements

• A Bachelor's degree in chemistry or a related field is highly desirable, OR a Master's degree with 7 or more years of relevant regulatory experience, OR an advanced degree with 5 or more years of applicable regulatory experience.

• Prior experience with radiopharmaceutical therapies (both therapeutic and diagnostic), radiopharmaceutical cold kits, and/or PET drug products is essential.

• Demonstrated experience in independently authoring IND, IMPD, NDA, MAA, and/or DMF CMC sections is required.

• Familiarity with phase-appropriate data requirements for regulatory filings is preferred.

• Proven track record of strong leadership and teamwork in a cross-functional industry environment.

• Exceptional written and verbal communication abilities.

🏝️ 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 for 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). For Phoenix, AZ, Puerto Rico, and RayzeBio Exempt, Non-Exempt, Hourly Employees: 160 hours of annual paid vacation for new hires (with manager approval), 11 national holidays, and 3 optional holidays. Based on eligibility*, additional time off may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs, along with an annual Global Shutdown between Christmas and New Year's Day.