Senior Manager - Regulatory Data Management Amgen Technology Private Limited

5.0 - 10.0 years

5 - 10 Lacs

Hyderabad, Telangana, India

On-site

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As the Senior Manager of Regulatory Data Management in Hyderabad, you will be instrumental in shaping and implementing the system-based framework for regulatory data management at Amgen. This pivotal role involves leading the Data Management team within Amgen India (AIN), engaging with GSIM leadership, and collaborating with cross-functional partners who utilize the company's Regulatory Information Management (RIM) system. You will be responsible for building and leading an impactful team from the ground up, ensuring the delivery of key operational metrics and maintaining compliance. Roles & Responsibilities Build and lead an impactful team, focused on delivering global regulatory data management services within the regulatory information management system. Develop a collaborative and inclusive team culture that promotes innovation and continuous improvement. Ensure the team meets key operational metrics and compliance standards , maintaining high levels of accuracy and efficiency. Drive continuous improvement initiatives to enhance service delivery and operational processes. Minimize potential errors by establishing policies & processes for data usage. Supervise the provision of high-quality data processing, system utilization, and data management services to global clients. Develop and implement comprehensive training programs to ensure team members are skilled and knowledgeable in regulatory data management practices. Stay abreast of regulatory developments and ensure the team follows all relevant regulations and standards. What We Expect of You Basic Qualifications Doctorate degree and 2 years of regulatory systems experience OR Master's degree and 8 to 10 years of regulatory systems experience OR Bachelor's degree and 10 to 14 years of regulatory systems experience OR Diploma and 14 to 18 years of regulatory systems experience Advanced knowledge of Veeva Vault RIM . Proven leadership in regulatory data management . Hands-on ability to work on data-centric processes and systems . Strong knowledge of handling structured and unstructured data. Demonstrated excellence in change management and key customer engagement . Preferred Qualifications Experience with delivering compliance assurance within a large company. Experience with large-scale enterprise systems in the Biotech/Pharmaceutical industry . 5 years of proven experience in regulatory operations, submission management . Excellent understanding of Regulatory Affairs business complexity and process interdependencies . Experience with regulatory data in Regulatory Affairs, Research, Development, Quality Management, or related area. Demonstrated experience in building and leading successful teams . Sharp learning agility and analytical thinking. Proven and advanced interaction with global key customers.

Posted 17 hours ago

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