Bristol Myers Squibb

with Us:- Challenging.- Meaningful.- Life-changing.- Those aren't 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.- You'll 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.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 ( renewals, label updates, and safety reports) in the BMS 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 (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 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.- 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. 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