Associate Director – Established Brands Regulatory Lead
Location: Hyderabad, Telangana, India
Job Type: Full-Time | Individual Contributor
Department: Global Regulatory Sciences (GRS) – Drug Development
Job ID: R1596840
About Bristol Myers Squibb (BMS)
At BMS, we are committed to transforming patients’ lives through innovative therapies across diverse therapeutic areas. Our Established Brands portfolio plays a vital role in the company’s diversification strategy, supporting sustainable growth and maximizing the impact of marketed products globally. Join a company that prioritizes regulatory excellence, scientific integrity, and cross-functional collaboration to deliver safe and effective medicines worldwide.
Position Summary
The Associate Director – Established Brands Regulatory Lead is responsible for the end-to-end regulatory lifecycle management of marketed Established Brands within the BMS portfolio. This role ensures compliance with global and regional regulatory requirements, including renewals, label updates, post-marketing safety reports, and strategic submissions. The incumbent will lead regulatory strategy, risk mitigation, and cross-functional collaboration to enable successful regulatory outcomes and support portfolio optimization initiatives.
Key Responsibilities
Global Regulatory Leadership:
Develop and execute regulatory strategies for assigned Established Brands, ensuring marketing authorization (MA) compliance globally.
Represent Global Regulatory Sciences (GRS) at the Established Brands Global Program Team (GPT).
Oversee portfolio optimization, including study terminations, product deletions, and SKU management.
Review Clinical Study Reports and contribute content to DSURs, PSURs/PBRERs, and Annual Reports.
Lead cross-functional rapid response teams to define strategies and meet health authority deadlines.
Ensure post-marketing requirements, regulatory correspondence, and commitments are tracked and addressed using Verity.
Proactive Problem Solving & Risk Management:
Monitor evolving regulatory landscapes (FDA, EMA, international authorities) and identify potential risks early.
Proactively resolve regulatory challenges and escalate when necessary to ensure compliance.
Cross-Functional Collaboration:
Partner with EBMT, Global Development, Pharmaceutical Supply (GPS), Commercial, Legal, and Medical Affairs teams.
Provide regulatory guidance to support global and regional project needs and strategic decision-making.
Stakeholder Engagement:
Build and maintain productive relationships with internal and external stakeholders to ensure smooth execution of regulatory activities.
Represent the regulatory function across project teams, alliances, and organizational initiatives.
Qualifications & Experience
Education:
Ph.D., M.D., PharmD, M.S. in Pharmacy or Life Sciences, or equivalent professional experience in pharmaceutical regulatory affairs.
Experience:
Minimum 10 years of pharmaceutical industry experience, including significant experience in Regulatory Affairs/Sciences.
Demonstrated expertise in managing lifecycle regulatory activities, including safety, CMC variations, and new therapeutic indications.
Experience in US/EU regulatory environments across multiple therapeutic areas.
Proven ability to write and review high-level regulatory documents and submissions.
Experience in matrix-driven environments with the ability to lead cross-functional teams.
Skills & Competencies:
Strong strategic thinking and planning to ensure successful regulatory outcomes.
Excellent written and verbal communication skills, with the ability to influence senior stakeholders.
Strong analytical and organizational skills to manage multiple complex projects in a fast-paced, ambiguous environment.
In-depth understanding of evolving regulatory policies, precedents, and competitive landscapes.
Demonstrated ability to provide regulatory guidance for divestitures, transitions, and portfolio optimization.
Why Join BMS
Contribute to globally impactful therapies while working in a supportive, inclusive environment.
Collaborate with high-performing cross-functional teams to drive regulatory excellence.
Opportunity to influence the lifecycle management of Established Brands and support BMS’s growth strategy.
BMS is committed to diversity, equity, and inclusion, and provides reasonable accommodations to ensure all employees can excel.
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