Associate Director, Commercial Regulatory Affairs

Bristol Myers Squibb • Princeton, NJ

15d • Hybrid

About The Position

Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us . The role of Associate Director of US Commercial Regulatory Affairs requires the ability to apply complex scientific and expert regulatory advice and risk assessment for the development of promotional campaigns and materials for an assigned product/therapeutic area in order to help ensure the Company’s objectives are met. This individual will ensure materials are consistent with BMS guiding principles, PhRMA guidelines, FTC guidelines, and applicable FDA regulations and guidance.

Requirements

• Minimum education of a bachelor's degree is required; advanced degree preferred (MS, PhD, PharmD, JD).
• Minimum of seven (7) years of pharmaceutical experience (e.g., Medical promotional review) in which three (3) to five (5) years of experience is in regulatory promotional review.
• Experience providing risk assessment to interdisciplinary teams on promotional materials and activities for marketed products and strong interest in FDA advertising and promotion regulations including guidance(s).
• Ability to propose regulatory strategies for advertising and promotion campaigns, disease awareness, and institutional campaigns.
• Proven aptitude to analyze and interpret efficacy and safety data.
• Experience communicating and negotiating with OPDP/APLB.
• Demonstrated ability to negotiate and influence others to help build team collaboration.
• Excellent interpersonal skills, flexibility, adaptable to a changing environment and adeptness to communicate effectively with cross functional teams and with business partners across the company.

Responsibilities

• Provides regulatory advice, risk assessment and mitigation strategies to Commercial Teams, Medical Affairs, Public Affairs, Value Access and Payment, and other internal groups, on all promotional materials, including concepts, disease awareness, and institutional campaigns on assigned product/therapeutic area.
• Provides solution-oriented and innovative advice to meet the company’s objectives and goals.
• Provide strategic advice for the development of Advertising and Promotional Labeling Branch (APLB) and Office Of Prescription Drug Promotion (OPDP) advisory submissions and subpart E and H submissions.
• Ensure full regulatory compliance of all promotions with approved labeling and /or FDA guidance.
• Ensure regulatory compliance with subpart E/H and 2253 regulations.
• Lead training for Commercial teams on subpart E/H, 2253 regulations and FDA regulations on advertising and promotion.
• Ensure monitoring and maintenance of knowledge of the evolving regulatory landscape to provide innovative solutions and advice.
• Develop and maintain strong working relationships with internal customers, including Commercial, Medical, Public Affairs, Legal and Compliance.
• Integrate compliance considerations into risk assessment by partnering with Legal/Compliance colleagues.
• Provide advice and guidance as appropriate on the development of draft product labeling to ensure commercially viable US labeling upon which future promotion and advertising will be based.
• Provide input on process improvement and BMS guiding principles as needed.
• Provide direct management to individuals depending on assignment.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees