Associate Director, Regulatory Affairs
Bristol Myers Squibb
5 hours ago
Remote friendly (United States)
United States
Corporate Functions
Job Responsibilities
- Global Regulatory Lead for radiopharmaceutical (RPT) programs.
- Develop clinical and nonclinical regulatory strategy for therapeutic and diagnostic (imaging) products, including timing and nature of global regulatory interactions.
- Author regulatory documents required for regulatory interactions.
- Stay current on relevant disease areas, including anticipating changes in standard of care as perceived by regulatory authorities and key customers.
- Maintain expert knowledge of the relevant regulatory landscape.
- Maintain relationships with regulators and represent the company to regulators.
- Lead preparation and submission of regulatory filings (e.g., IND, IND amendments, CTA/IMPD, annual report, briefing documents, iPSP/PIP, safety reports, marketing applications).
- Lead preparation for and conduct Regulatory Authority interactions (e.g., FDA teleconferences, EMA scientific advice).
Basic Qualifications
- Bachelor’s degree or higher.
- 7+ years of hands-on regulatory experience.
- Experience with therapeutic and diagnostic (imaging) radiopharmaceutical product development; familiarity with radioisotopes such as 68Ga, 177Lu, 225Ac, 161Tb, F18, Y90, etc.
- Experience with nonclinical and clinical regulatory strategy in oncological indications.
- Demonstrated leadership and teamwork in a cross-functional, fast-paced environment.
- Previous experience interacting with Regulatory Authorities.
Skills (Required/Preferred)
- Excellent written and verbal communication.
- Highly organized; able to multitask and handle pressure.
- Meticulous with detail and precision.
- Ability to execute independently from start to finish on complex tasks.
- Proficient in MS Office (Outlook, Word, PowerPoint, Excel, Teams) and video conferencing.
- Strong communication and interpersonal skills.
- Assertive, proactive, professional, confident.
- Excellent ethics and integrity.
- Flexibility in cross-functional, dynamic environments.
- Ability to apply AI to improve team execution and decision-making.
Benefits
- Health coverage (medical, pharmacy, dental, vision).
- Wellbeing support programs (e.g., BMS Well-Being Account, BMS Living Life Better, EAP).
- Financial wellbeing/protection (e.g., 401(k), short/long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, identity theft benefit, legal support, survivor support).
- Paid Time Off (flexible time off or paid vacation, depending on employee type/location).
Compensation Overview
- Remote (United States): US $173,217–$209,899.
- San Diego (CA): US $190,539–$230,888.
Application Instructions
- If the role interests you but doesn’t perfectly match your resume, the company encourages applying anyway.
- Global Regulatory Lead for radiopharmaceutical (RPT) programs.
- Develop clinical and nonclinical regulatory strategy for therapeutic and diagnostic (imaging) products, including timing and nature of global regulatory interactions.
- Author regulatory documents required for regulatory interactions.
- Stay current on relevant disease areas, including anticipating changes in standard of care as perceived by regulatory authorities and key customers.
- Maintain expert knowledge of the relevant regulatory landscape.
- Maintain relationships with regulators and represent the company to regulators.
- Lead preparation and submission of regulatory filings (e.g., IND, IND amendments, CTA/IMPD, annual report, briefing documents, iPSP/PIP, safety reports, marketing applications).
- Lead preparation for and conduct Regulatory Authority interactions (e.g., FDA teleconferences, EMA scientific advice).
Basic Qualifications
- Bachelor’s degree or higher.
- 7+ years of hands-on regulatory experience.
- Experience with therapeutic and diagnostic (imaging) radiopharmaceutical product development; familiarity with radioisotopes such as 68Ga, 177Lu, 225Ac, 161Tb, F18, Y90, etc.
- Experience with nonclinical and clinical regulatory strategy in oncological indications.
- Demonstrated leadership and teamwork in a cross-functional, fast-paced environment.
- Previous experience interacting with Regulatory Authorities.
Skills (Required/Preferred)
- Excellent written and verbal communication.
- Highly organized; able to multitask and handle pressure.
- Meticulous with detail and precision.
- Ability to execute independently from start to finish on complex tasks.
- Proficient in MS Office (Outlook, Word, PowerPoint, Excel, Teams) and video conferencing.
- Strong communication and interpersonal skills.
- Assertive, proactive, professional, confident.
- Excellent ethics and integrity.
- Flexibility in cross-functional, dynamic environments.
- Ability to apply AI to improve team execution and decision-making.
Benefits
- Health coverage (medical, pharmacy, dental, vision).
- Wellbeing support programs (e.g., BMS Well-Being Account, BMS Living Life Better, EAP).
- Financial wellbeing/protection (e.g., 401(k), short/long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, identity theft benefit, legal support, survivor support).
- Paid Time Off (flexible time off or paid vacation, depending on employee type/location).
Compensation Overview
- Remote (United States): US $173,217–$209,899.
- San Diego (CA): US $190,539–$230,888.
Application Instructions
- If the role interests you but doesn’t perfectly match your resume, the company encourages applying anyway.