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Amgen
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Senior Manager - Regulatory Data Management

Senior Manager - Regulatory Data Management

Amgen

2 - 7 years

10 - 14 Lacs

Hyderabad

Posted:5 days ago| Platform:

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Skills Required

Change management Operational excellence Data management Analytical Oncology Data processing Information management Continuous improvement Operations

Work Mode

Work from Office

Job Type

Full Time

Job Description

The Global Submission and Information Management (GSIM) team brings strategic technical expertise to drive operational excellence, innovation, and technical compliance for Amgens global regulatory submission and information management. Ensures smooth, compliant data flows among functional areas, external partners, and regulatory authorities while designing and implementing process improvements, digital technologies, data standards, and organizational change management to achieve business results.

The Senior Manager of Regulatory Data Management will help shape and implement the system based framework for regulatory data management at Amgen. The role involves leading the Data Management team in AIN, engaging with GSIM leadership and cross-functional partners who use the company Regulatory Information Management system. This role is pivotal in building and leading an impactful team from the ground up, ensuring the delivery of key operational metrics and maintaining compliance.

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 utilisation 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 is 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 OR
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

What you can expect of us

As 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.

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Senior Manager - Regulatory Data Management