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Associate Director, Commercial Regulatory Affairs

Posted May 11
Full Time
On Site
Madison, New Jersey

Job Description

Working with Us

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 rich in diversity. 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.

 

Summary:

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.  Individual will ensure materials are consistent with BMS guiding principles, PhRMA guidelines, FTC guidelines, and applicable FDA regulations and guidances.

 

Responsibilities include:

  • 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 Office of Prescription Drug Promotion or Advertising, Promotion, and Labeling Branch advisory submissions and sub part e/h submissions.

  • Ensure full regulatory compliance of all promotions with approved labeling and /or FDA guidances.

  • Ensure regulatory compliance with sub part e and 2253 regulations.

  • Lead training for Commercial teams on sub part e, 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.

  • Pursues and understands diverse perspectives inside and outside BMS to provide risk assessment and mitigation strategies.

  • 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.

  • Engages with colleagues within the department to help support them in their roles and development.

  • May provide direct management to individuals depending on assignment/department needs. 

  • Proactively seeks opportunities to learn and develop leadership skills.

 

Qualifications:

  • BS required; advanced degree preferred (MS, PhD, PharmD, JD)

  • Minimum of 3-5 years Regulatory promotional review or related 5 to 8 years pharmaceutical experience (e.g., Medical 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 is a plus.

  • Organizational skills and ability to pay attention to details. Demonstrated ability to negotiate and influence others to help build team collaboration.

  • Excellent verbal, communication, and presentation skills

  • 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.

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

 

Uniquely Interesting Work, Life-changing Careers

With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

 

On-site Protocol

BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

 

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.