Associate Director Commercial Regulatory Affairs (Hybrid)

Working with Us

Challenging. Meaningful. Life-changing. Those arent 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. Youll 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 : Director Commercial Regulatory Affairs

Description : 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 Companys 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 companys 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 guidances
• 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
• 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
• Provide direct management to individuals depending on assignment
• Proactively seeks opportunities to learn and develop leadership skills

Qualifications :

If you come across a role that intrigues you but doesnt 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.

Compensation Overview :

The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job such as required skills where the job is performed the employees work schedule job-related knowledge and experience. Final individual compensation will be decided based on demonstrated experience.

Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits please visit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following : 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 Years 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.

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 a supportive culture promoting global participation 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 an 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 . Visit 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.

If you live in or expect to work from Los Angeles County if hired for this position please visit this page for important additional information : data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Required Experience :

Director

Key Skills

Proofreading,Adobe Acrobat,FDA Regulations,Manufacturing & Controls,Biotechnology,Clinical Trials,Research & Development,GLP,cGMP,Product Development,Chemistry,Writing Skills

Employment Type : Full-Time

Experience : years

Vacancy : 1