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Bristol Myers Squibb - Associate Director

Bristol Myers Squibb - Associate Director

Bristol Myers SquibbHyderabad, India
1 day ago
Job description

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.

    • (ref : iimjobs.com)

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