Senior Manager - Regulatory Data Management

Amgen Inc. (IR); Hyderabad; On-site; INR 13,487,000 - 21,195,000; Full time

Job summary

Amgen seeks a Senior Manager for Regulatory Data Management to lead the Data Management team within GSIM, driving data integrity and compliance across global regulatory submissions.

You will build a high-performing team in AIN, shape RIM strategy, and partner with cross-functional leaders to ensure timely, accurate data flows and continuous improvement.

Qualifications

• Doctorate or Master's with extensive regulatory systems experience.
• Bachelor's degree with 10–14 years regulatory systems experience.
• Diploma with 14–18 years regulatory systems experience.
• Advanced knowledge of Veeva Vault RIM.
• Proven leadership in regulatory data management and change management.

Responsibilities

• Lead the Data Management team in GSIM to ensure compliant data flows.
• Design and implement data management policies and processes.
• Drive continuous improvement and service delivery metrics.
• Oversee data processing accuracy and system utilization.
• Develop and deliver training to ensure regulatory data mgmt expertise.
• Engage with global stakeholders to ensure regulatory information management alignment.

Skills

Regulatory data management

Leadership

Data governance

Change management

Stakeholder engagement

Education

Doctorate degree

Master's degree

Bachelor's degree

Diploma

Tools

Veeva Vault RIM

Job description

Career Category Safety Job Description Join Amgen’s Mission of Serving Patients

At 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.

Senior Manager - Regulatory Data Management

The Global Submission and Information Management (GSIM) team brings strategic technical expertise to drive operational excellence, innovation, and technical compliance for Amgen's 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

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.

About Us

As 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 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. Please contact us to request accommodation.

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen