Senior Manager, Established Brands Regulatory Lead

Location: Prakāshamnagar

Working with Us

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Position Summary

The Established Brands portfolio plays a significant role in BMS's diversification strategy. The Senior Manager, Established Brands Regulatory Lead takes ownership of one or more 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.
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.
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 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., Pharm

D, M.S. in Pharmacy or Life Sciences or equivalent professional experience.
7+ years overall pharma experience, including prior position(s) with Regulatory Affairs/Sciences.

Specific Knowledge, Skills, Abilities

Solid 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…