Manager Labeling

Amgen

  • Hyderabad, Telangana
  • Permanent
  • Full-time
  • 2 months ago
Career Category RegulatoryJob DescriptionJoin Amgen’s Mission of Serving PatientsAt Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.In this vital role, you will be responsible for planning, coordinating, and executing global labeling compliance activities to meet regulatory requirements across multiple regions. Working in close collaboration with cross-functional teams—such as Regulatory Affairs, Quality, Clinical, Operations, and Supply Chain—you will ensure that labeling processes, documentation, and systems remain accurate and inspection-ready. You will act as a subject matter expert in global labeling requirements, driving continuous improvement initiatives and upholding high-quality standards.Key Responsibilities
Global LabelingCoordinate end-to-end labeling changes (including updates, reviews, and approvals) ensuring alignment with regional and international regulations.Maintain and refine labeling templates, SOPs, and related documentation to sustain consistency and compliance.Cross-Functional CollaborationCollaborate with local, regional, and global teams—including Regulatory Affairs, Quality, and Supply Chain—to identify labeling requirements, address challenges, and meet project milestones.Communicate clearly and proactively with relevant stakeholders, providing expertise on labeling processes and compliance requirements.Planning & ExecutionDevelop detailed project plans and timelines for labeling initiatives, ensuring completion within defined schedules.Monitor progress, identify potential risks, and implement corrective actions to keep projects on track.Process Improvement & ComplianceIdentify opportunities to streamline labeling workflows and enhance efficiency, driving continuous improvement within the labeling function.Support inspection readiness by maintaining up-to-date records, robust quality checks, and accurate documentation for audit purposes.Technical & Operational SupportPerform critical reviews of artwork, translations, and labeling content to verify accuracy and adherence to regulatory standards.Troubleshoot issues related to labeling systems, ensuring timely resolution and minimal operational disruption.Mentoring & Knowledge SharingProvide guidance and training to junior team members and new hires on labeling standards, tools, and best practices.Foster a culture of knowledge-sharing and continuous learning to build expertise within the team.Qualifications
Basic Qualifications:Master’s degree and 6 to 8 years of directly related experience ORBachelor’s degree and 8 to 10 years of directly related experience ORDiploma and 10 to 12 years of directly related experienceRequired QualificationsKnowledge of end-to-end labeling.Knowledge of Labeling Management Systems (e.g., Veeva Vault) and related document management tools.Strong knowledge of global regulatory labeling requirements, especially for pharmaceuticals or biologics.Proven track record in project planning and execution, with strong organizational and problem-solving skills.Excellent communication skills, with the ability to collaborate effectively in a global, cross-functional environment.Experience in continuous improvement methods to enhance labeling processes and efficiency.Soft Skills:Excellent written/oral communication skills and attention to detailAbility to effectively demonstrate leadership in a team environment which requires negotiation, persuasion, collaboration, and analytical judgment;Proficient time and project management skills.Self-starter with a drive and perseverance to achieve results.What we expect from youWe are all different, yet we all use our unique contributions to serve patients.What you can expect of usAs we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.Apply nowfor a career that defies imaginationObjects in your future are closer than they appear. Join us.careers.amgen.comAs an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment..

Amgen