Job Title
Manager, International Labeling Operations
Division
Research and Development / Global Regulatory, Safety and Biometrics / Global Labeling & Mature Products Strategy / Global Regulatory Collaboration and Service Center
Direct Manager
Associate Director, Global Regulatory Collaboration & Service Center
Position Summary
Manage a team of individuals whose focus is driving the labeling documentation for Regulatory submissions and commercialization of products. Be an active member in both departmental and global improvement projects providing operational and project management guidance as the departmental SME. Mentor and guide departmental specialists and coordinators to maintain accurate, consistent, prioritization the book of work, procedural documents and compliant labeling documentation for submissions to the Health Authorities worldwide.
Ensure International Labeling Operations team meets or exceeds its service commitments
Direct Reports
Key Business Partners
International Strategy Leads, Country Regulatory Managers, Global Regulatory Strategy Operations, Global Packaging Technology, Manufacturing Launch Team lead, Site-to-Market Team Lead, Labeling Leads, CMC managers, US Labeling Specialists, Replenishment Planners, Global Dossier Management, Regulatory Information Management (RIM) Services, Pharmaceutical Labeling Proofreader, Pharmaceutical Labeling Operations Coordinator, International Regulatory Affairs Specialist
Position Responsibilities
Manages International labeling Operations Team to ensure all activities are aligned, compliant, and employ best practice and meet GRSB and BMS strategic imperatives
Guides & Mentors International Labeling Operations team to support International registrations and International launches for new chemical entities and labeling maintenance for marketed products
Actively manages and develops direct reports; ensures creation of annual objectives, providing continuous feedback and completion of performance check-ins in accordance with company standards and timelines; oversees training on appropriate labeling procedures, procedural documents, and new health authority regulations.
Advises, identifies, evaluates, and provides guidance related to International labeling, in consultation with global regulatory and project development teams
Maintains and contributes to Labeling Operations’ departmental SOPs and process flow maps while actively assessing for improvements.
Being the point of contact for various worldwide artwork and labeling queries.
Contributes to special process-related initiatives with strong knowledge and understanding of labeling processes and other related processes; participates in global regulatory and project development teams as necessary to identify, evaluate, and provide guidance on operational issues.
Maintains up-to-date knowledge of extensive and complex International regulatory labeling requirements, assessing and communicating impact on BMS business and products (working with BMS policy group as appropriate);
Partners with and influences BMS Quality Organizations in relation to the end-to-end International labeling process and audit / inspection readiness; ensures compliance (external/internal) and appropriate labeling responses during audit and inspections, and manages labeling Corrective And Preventive Actions (‘CAPA), to meet timely completion of labeling-related CAPAs, analyze overall inspection and audit observations related to International labeling and identify areas for improvement
Proactively identifies risks and issues, and develops solutions to challenging areas related to assigned projects in the interest of keeping projects streamlined and moving forward.
Desired Experience
Required:
Bachelor or Masters in Sciences or related discipline and ³ 5 years’ experience in regulatory (labeling and artwork development preferred)
Must possess an excellent command of language (English)
Robust knowledge of medical and scientific terminology, and biopharma manufacturing complexities
Excellent communication and organizational skills and a meticulous eye for detail
Proficiency in standard office technology, including Microsoft Suite, Outlook Mail/Calendar and willing to learn additional applications as needed
Experience working on multi-disciplinary teams and projects including direct people management
Ability to align personal objectives with the Packaging and Labeling and business strategies in order to make the best possible judgments
Professional knowledge of rigorous pharmaceutical and/or scientific documentation practices and change control processes (e.g. revision control)
Excellent knowledge of labeling regulations and HA approval structure outside of assigned region or countries, including but not limited to USA and EU.
Ideal Candidates Would Also Have:
Project Management experience
Knowledge / understanding of another language in a region supported (e.g. Spanish, Arabic, Chinese)
Other qualifications:
Direct People Management Experience preferred
Experience of the complexities of International Health Agency requirements
US military experience will be considered towards industry experience requirements
- Direct BMS experience may be considered instead of Labeling experience/ college degree/ managerial experience
Development Value
Potentially develop into Quality role or Head of GRCSC or Global Labeling Lead
About Bristol-Myers Squibb
Bristol-Myers Squibb is a diversified specialty biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. The Bristol-Myers Squibb North America Capability Center is a state-of-the-art facility in Tampa, Florida, providing strategic capabilities for delivering end-to-end process excellence and innovation.
The center provides high knowledge-based capabilities and services across multiple disciplines and is part of our ongoing efforts in continuous process improvement. At the North America Capability Center we continue to explore ways to simplify processes and increase the efficiency and effectiveness of our operations.
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
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.
Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or any part of the recruitment process direct your inquiries to [email protected]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
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