Director of Regulatory Affairs – Clinical, NonClinical

November 6

🏄 California – Remote

Although this job is listed in California, this company may be open to hiring remote in other states.

💵 $210.6k - $255.2k / year

⏰ Full Time

🔴 Lead

🚔 Compliance

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Bristol Myers Squibb

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Biotechnology • Pharmaceuticals

Bristol Myers Squibb is a global biopharmaceutical company that is dedicated to discovering, developing, and delivering innovative medicines that help patients prevail over serious diseases. Their areas of focus include cardiovascular health, cell therapy, immunology, and oncology. With a commitment to transforming patient outcomes through pioneering science, Bristol Myers Squibb partners with a worldwide network of researchers, healthcare providers, and other stakeholders. They aim to lead in innovation for patients while fostering diversity and inclusion within their workforce.

10,000+ employees

Founded 1887

🧬 Biotechnology

💊 Pharmaceuticals

📋 Description

• Global Regulatory Lead for a cutting edge RPT program • 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, authoring and submission of regulatory filings (e.g., pre-IND meeting materials, INDs, 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 • 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,225-Ac, 161Tb, F18, Y90, etc. • Experience with clinical regulatory strategy in prostate cancer • Demonstrable record of strong leadership and teamwork in a cross-functional, fast-paced industry environment.

🏖️ Benefits

• Medical, pharmacy, dental and vision care. • Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). • Financial well-being resources and a 401(K). • Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. • Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. • Parental, caregiver, bereavement, and military leave. • Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. • Other perks like tuition reimbursement and a recognition program.