Associate Director – Regulatory Affairs
Bristol Myers Squibb
full-time
Posted on:
Location Type: Remote
Location: California • United States
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Salary
💰 $173,217 - $209,899 per year
Job Level
About the role
- 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 and conducting Regulatory Authority interactions, such as FDA teleconferences, EMA scientific advice, etc.
Requirements
- Bachelor’s degree or higher
- 7 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.
- Our benefits include: Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory strategyregulatory document authoringregulatory filingsINDCTAIMPDsafety reportsmarketing applicationstherapeutic product developmentdiagnostic product development
Soft Skills
leadershipteamworkcross-functional collaborationcommunication
Certifications
Bachelor’s degree