Senior Manager, Regulatory Affairs

🕒 Yesterday

🏄 California – Remote

🏄 California – Remote

💵 $149.9k - $181.6k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

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Bristol Myers Squibb

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1887

🧬 Biotechnology

💊 Pharmaceuticals

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.

📋 Description

• Serves as Global Regulatory Lead (GRL) • Regulatory strategy, including timing and nature of global regulatory interactions. • Work with cross-functional teams to communicate regulatory strategies and upcoming program submissions/interactions. • Lead the preparation and submission of regulatory filings (e.g., IND, IND amendments, Diversity Plans, CTA/IMPD, annual report, briefing document, iPSP/PIP, safety reports, marketing applications). • Lead the preparation for Health Authority Interactions. • Generation 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.

🎯 Requirements

• Bachelor’s degree or higher • 5 or more years of hands-on regulatory experience, experience of clinical regulatory strategy in oncology would be a distinct advantage. • Demonstrable record of strong leadership and teamwork in a cross-functional industry environment. • Radiopharmaceutical therapy is a plus. • Excellent written and verbal communication 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 environment • Applies AI to improve team execution and decision‑making

🏖️ 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.