Bristol Myers Squibb

Senior Director, Regulatory Affairs – Early Development

Bristol Myers Squibb

full-time

Posted on:

Location Type: Remote

Location: California • United States

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Salary

💰 $241,768 - $292,966 per year

Job Level

Senior

About the role

  • Global Regulatory Lead for cutting edge radiopharmaceutical programs.
  • Clinical and nonclinical regulatory strategy for therapeutic and diagnostic radiopharmaceutical products, including timing and nature of global regulatory interactions.
  • Experience in clinical regulatory strategy in the Early Development or first-in-human space.
  • 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.
  • Responsible for direct reports.

Requirements

  • Bachelor’s degree or higher
  • 10 or more years of hands-on regulatory experience, including authoring and providing strategic input to stakeholders
  • Experience with nonclinical and clinical regulatory strategy in oncological indications
  • Demonstrable record of strong leadership and teamwork in a cross-functional industry environment.
  • Proficient in MS Office (Outlook, Word, PowerPoint, Excel, and Teams) and video conferencing
  • Should be assertive, proactive, professional, and confident
  • Excellent professional ethics and integrity.
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.
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
regulatory strategyauthoring regulatory documentsclinical regulatory strategynonclinical regulatory strategyregulatory filingsINDCTAsafety reportsmarketing applicationsoncological indications
Soft Skills
leadershipteamworkassertivenessproactivityprofessionalismconfidenceethicsintegrity