Senior Manager, Regulatory Affairs
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Job Description
Senior Manager overseeing regulatory affairs for innovative radiopharmaceutical therapies at RayzeBio. Managing clinical and nonclinical regulatory strategies and submissions for oncological products.
Responsibilities:
- Global Regulatory Lead for a cutting edge RPT programs
- Clinical and nonclinical regulatory strategy for therapeutic and diagnostic (imaging) products, including timing and nature of global regulatory interactions.
- Authoring of regulatory documents that are required for regulatory interactions.
- Keeping up to date in the relevant disease areas, including anticipating changes in standard of care as perceived by regulatory authorities and other key customers.
- Maintaining an expert knowledge of the relevant regulatory landscape.
- Maintaining a relationship with and representing the company to regulators.
- Lead the preparation and submission of regulatory filings (e.g., IND, IND amendments, CTA/IMPD, annual report, briefing document, iPSP/PIP, safety reports, marketing applications).
- Lead the preparation for Health Authority Interactions.
Requirements:
- Bachelor’s degree or higher
- 5 or more years of hands-on regulatory experience
- Experience with therapeutic and diagnostic (imaging) radiopharmaceutical product development and familiarity with radioisotopes such as 68Ga, 177Lu, 225Ac, 161Tb, F18, Y90, etc.
- Experience with nonclinical and clinical regulatory strategy in oncological indications
- Demonstrable record of strong leadership and teamwork in a cross-functional, fast-paced industry 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 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. All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.
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