Senior Manager - Regulatory Data Management

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.

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

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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.

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