Associate Director- Established Brands Regulatory Lead

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Position Summary

The Established Brands portfolio plays a significant role in BMS's diversification strategy. The Associate Director, Established Brands Regulatory Lead takes ownership of several Established Brands and oversees the lifecycle of marketed products, ensuring compliance with global/regional regulatory requirements (e.g., renewals, label updates, and safety reports) in the BMS footprint.

Duties/Responsibilities

• Global Regulatory Leadership:
  • Lead the regulatory strategy for assigned Established Brands assets and ensure the maintenance of marketing authorizations (MAs) globally through collaboration with regional and country regulatory leads
  • Will represent GRS at the Established Brands Global Program Team (GPT)
  • Support portfolio optimization (study terminations, product and SKU deletion)  
  • Identify and escalate regulatory risks, ensuring seamless collaboration across teams to drive successful regulatory outcomes.
  • Review  Clinical Study Reports and other relevant documents, provide content to Safety Aggregate Reports (DSUR,  PSUR/PBRER, Annual Report), and to HA requests/responses
  • Lead  cross-functional rapid response teams to define response strategy and ensure that HA deadlines are met
  • Oversee the lifecycle of marketed products, ensuring compliance with global/regional regulatory requirements (e.g., renewals, label updates, and safety reports) and ensure regulatory correspondence, postmarketing requirements and commitments are addressed and tracked in Verity.
  • Proactively prioritize and complete multiple projects within established deadlines.
  • Provide regulatory strategic guidance and oversight for deletion proposals put forth by the Worldwide Established Brands Steering Committee (WWEB SC) and transition of assets from In-line/Key Brand to an Established Brand.  
  • Work with the Regulatory Divestiture Lead on proposed EB divestiture assessments and support transition to buyer
• Proactive Problem Solving:
  • Understand the regulatory landscape and identify potential issues early, proactively resolve them, and escalate as necessary.
• Cross-Functional Collaboration:
  • Collaborate with EBMT, as well as Enterprise-wide colleagues in  Global Development and Pharmaceutical Supply (GPS), Commercial, Legal, and Medical organizations to ensure the regulatory strategy supports global and regional needs.
• Stakeholder Engagement:
  • Build and maintain productive relationships with internal teams to ensure the smooth execution of regulatory activities.
• Regulatory Landscape :
  • Maintain awareness of evolving FDA, EMA and international regulations and interpretation, competitive landscape, regulatory precedents, and work cross-functionally to implement those evolved regulations for the assigned projects.

Reporting Relationship

Individual Contributor

Drug Development (DD) / Global Regulatory Sciences (GRS) / Global Regulatory Sciences HYD

Qualifications

Education/Experience/Licenses/Certifications:

• Scientific background, Ph.D., M.D., PharmD, M.S. in Pharmacy or Life Sciences or equivalent professional experience.
• 10+ years overall pharma experience, including prior position(s) with Regulatory Affairs/Sciences.

Specific Knowledge, Skills, Abilities:

• Significant experience in managing lifecycle regulatory activities, including new therapeutic indications, safety, and CMC variations.
• Solid knowledge and understanding of complex medical and scientific subject matter as well as evolving regulatory policy and guidance
• Solid knowledge of regulatory affairs (US or EU), preferably in multiple therapeutic areas.
• Strong depth and breadth of knowledge of the submission process and significant experience in writing high-level documents.
• Broad intelligence of the regulatory environment across key regions, with anticipation of future trends and their impact.
• Experience in leading a team in a matrix-driven environment.
• Expertise in driving strategic thinking and plans for successful regulatory outcomes.
• Strong interpersonal and organizational skills, including excellent written and verbal communication.
• Representation of the positions of the respective regulatory functions on project teams within BMS and across alliances.
• Setting priorities, working independently in a resource-constrained environment, and delivering in a timely manner.
• Strong influencing and persuasive skills, with a demonstrated ability to influence different styles and individuals at various organizational levels.
• Strong collaboration and analytical skills to ensure that emerging trends are thoroughly assessed and vetted for potential business implications.
• Managing multiple priorities and complex projects in an ambiguous environment.

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 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 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.

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: https://careers.bms.com/california-residents/

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