ob Title: Senior Manager – Established Brands Regulatory Lead
Location: Hyderabad, Telangana, India
Job ID: R1596841
Date Posted: 11/09/2025
Department: Global Regulatory Sciences
Bristol-Myers Squibb’s (BMS) Established Brands portfolio is a key driver of our global diversification strategy. We are seeking a Senior Manager – Established Brands Regulatory Lead to take full ownership of one or more Established Brands, overseeing the lifecycle of marketed products while ensuring strict compliance with global and regional regulatory requirements, including renewals, label updates, and safety reports. This role is an individual contributor position based in Hyderabad, reporting to the Global Regulatory Sciences (GRS) team.
1. Global Regulatory Leadership
Lead the regulatory strategy for assigned Established Brands, ensuring ongoing compliance and maintenance of marketing authorizations (MAs) globally.
Represent GRS at the Established Brands Global Program Team (GPT).
Support portfolio optimization efforts, including study terminations, product, and SKU deletions.
Identify and escalate regulatory risks proactively, ensuring cross-functional collaboration for successful outcomes.
Lead rapid response teams to define response strategies and ensure timely submission to Health Authorities (HAs).
Provide regulatory guidance on deletion proposals from the Worldwide Established Brands Steering Committee (WWEB SC) and manage transitions from In-line/Key Brand to Established Brand.
Collaborate with Regulatory Divestiture Leads on EB divestiture assessments and facilitate smooth transition to buyers.
2. Cross-Functional Collaboration & Stakeholder Engagement
Partner with colleagues across Global Development, Pharmaceutical Supply (GPS), Commercial, Legal, and Medical organizations to align regulatory strategy with business objectives.
Build and maintain strong relationships with internal teams to ensure seamless execution of regulatory activities.
3. Regulatory Expertise & Problem Solving
Maintain up-to-date knowledge of FDA, EMA, and international regulatory requirements, as well as evolving industry precedents.
Anticipate regulatory challenges, proactively resolve issues, and escalate as needed.
Provide strategic regulatory input on product lifecycle, including safety, CMC variations, and new therapeutic indications.
Education:
Ph.D., M.D., PharmD, M.S. in Pharmacy, Life Sciences, or equivalent professional experience.
Experience:
Minimum 7+ years in pharmaceutical regulatory affairs/sciences, with proven expertise in lifecycle management of marketed products.
Solid experience in multiple therapeutic areas, with deep knowledge of regulatory requirements in the US and EU.
Experience managing complex projects, including submissions, regulatory correspondence, and strategic planning in a matrix-driven environment.
Skills & Competencies:
Strong strategic thinking and problem-solving abilities.
Excellent written and verbal communication skills.
Proven ability to influence and collaborate across organizational levels.
Experience in prioritizing multiple initiatives and delivering in ambiguous, resource-constrained environments.
Deep understanding of global regulatory trends and the competitive landscape.
This is an opportunity to lead regulatory strategy for a portfolio of established pharmaceutical brands, driving compliance and supporting global business objectives. You will work with world-class teams, influence regulatory outcomes, and contribute to the success of life-changing medicines worldwide.
Apply Now to join a dynamic and collaborative global team at BMS in Hyderabad, India.
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