Senior Manager - Regulatory Data Management

Biopharma Careers; Hyderabad; On-site; INR 2,500,000 - 4,500,000; Full time

Benefits offered by this job

Total Rewards Plans

Job summary

Amgen in Hyderabad is seeking a Senior Manager for Regulatory Data Management to lead a global data management team within GSIM. You will shape a scalable, compliant data framework and drive operational excellence across regulatory information systems.

The role demands strong leadership, data-centric process design, and cross‑functional collaboration. Successful candidates bring advanced Veeva Vault RIM expertise, a track record in regulatory operations, and the ability to mentor a growing team

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

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 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.

Skills

Veeva Vault RIM

Data management leadership

Regulatory data management

Change management

Education

Doctorate in regulatory science

Master's degree

Bachelor's degree

Diploma in related field

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

What you will do

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

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.

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.