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Amgen
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Regulatory Affairs Manager

Regulatory Affairs Manager

Amgen

3 - 8 years

30 - 35 Lacs

Hyderabad

Posted:3 days ago| Platform:

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Skills Required

Automation Manager Quality Assurance Data management Manufacturing process Oncology Biochemistry Life sciences Manager Quality Control Regulatory affairs Data extraction

Work Mode

Work from Office

Job Type

Full Time

Job Description

Career Category Regulatory 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.

Job Summary:
Amgen is seeking a Manager, Regulatory Affairs CMC - Data Automation to shape the future of regulatory affairs by driving digital transformation and automation within CMC submissions. At Amgen, we are committed to innovation and excellence in regulatory science, offering a dynamic work environment where expertise in automation and AI can make a meaningful impact on regulatory efficiency and compliance.

Join us in revolutionizing regulatory submissions through cutting-edge data automation!

Key Responsibilities:

Support the implementation of automation and digital tools to streamline regulatory CMC documentation and submission workflows.
Assist in developing standardized templates and structured data formats for consistent and compliant submissions.
Contribute to projects focused on the application of AI and structured content/data management (SCDM) for regulatory use cases.
Coordinate with cross-functional teams, including Process Development, Quality, and Regulatory Affairs, to ensure alignment on automation and data standards.
Monitor industry trends and guidance to maintain up-to-date knowledge on digital and regulatory innovations.
Support the design and deployment of automated solutions for data extraction, conversion, and integration with regulatory platforms.
Participate in training activities to expand internal capabilities in digital tools and regulatory data automation.
Assist in regulatory interactions related to digital transformation, ensuring preparedness for engagement on evolving standards.

Basic Qualifications:

Doctorate degree OR

Master s degree and 3 years of directly related experience OR

Bachelor s degree and 5 years of directly related experience

Experience managing and leading a team in a regulatory or compliance environment

Preferred Qualifications:

Degree in life sciences, digital or data science, biochemistry, or chemistry

Experience leading global regulatory CMC submissions with knowledge of ICH guidance and global requirements

Background or basic experience in digitalization, automation, software development

Background in manufacturing, process development, quality control, or quality assurance

Hands-on experience with Veeva Vault platforms and regulatory technology solutions. What we expect from you
We are all different, yet we all use our unique contributions to serve patients.
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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Regulatory Affairs Manager