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RayzeBio (a Brystol Myers Squibb Company) is a dynamic biotechnology company headquartered in San Diego, CA. The company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio is developing innovative drugs against targets of solid tumors. Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals.
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.
Job Responsibilities
Essential duties and responsibilities include the following. Other duties may be assigned.
Director, Regulatory Chemistry, Manufacturing and Controls (CMC) will be responsible for working with the CMC teams to guide the CMC global regulatory strategy for RayzeBio radiopharmaceuticals leading to successful preparation and approval of Investigational New Drug applications (INDs), Clinical Trial Applications (CTAs), Drug Master Files (DMFs), New Drug Application (NDA), and Marketing Authorization Application (MAA) submissions
Participate in development and execution of global CMC regulatory strategies
Responsible for content development, compilation, maintenance, and review of the Quality Module for regulatory submissions (e.g., IND, IMPD, facility DMF, NDA, and MAA) for submission to global Health Authorities in compliance with departmental and regulatory standards
Prepare Health Authority responses & background packages (including participating/leading Health Authority meetings); and/or post-approval submissions
Independently manage and prioritize multiple complex projects
Manage and maintain strong working relationships with the regulatory CMC team and cross functional teams, participate on and/or lead multifunctional teams, handle and prioritize multiple projects and work
Work with the CMC teams to ensure CMC documentation (e.g., protocols, reports, specifications, analytical methods, batch records) that support development, process validation, and tech transfer activities meet regulatory standards
Support Manufacturing Change Controls for global impact and guide technical teams on global change management
Research and provide analysis of current US and international regulations and guidance
Provide ac 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
Communicate critical issues to Management
Education and Experience:
Bachelor’s degree or higher
10 or more years of hands-on regulatory experience
Prior experience in independently authoring IND, IMPD, NDA, MAA and/or DMF CMC sections is required
Understanding of phase-appropriate data requirements for regulatory filings is desired
Experience with complex aseptic formulations is essential
Demonstrable record of strong leadership and teamwork in a cross-functional industry environment
Excellent written and verbal communication skills
Skills:
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) 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
The starting compensation for this job is a range from $204,439-$276,594 plus incentive cash and stock opportunities (based on eligibility). The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed. Final, individual compensation will be decided based on demonstrated experience.
#RayzeBio
If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site Protocol
BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
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