Regulatory Affairs Manager – Data Automation
Location: Hyderabad, India
Job ID: R-218201
Posted On: July 2, 2025
Employment Type: Full-Time | On-Site
About the Role:
Amgen is seeking a Manager, Regulatory Affairs CMC – Data Automation to lead the charge in modernizing regulatory documentation through cutting-edge automation, AI, and structured data strategies. This role is ideal for a regulatory professional with a digital mindset, ready to shape the future of CMC submissions by implementing scalable, compliant, and streamlined digital solutions.
Key Responsibilities:
Drive implementation of digital tools and automation within CMC documentation workflows.
Develop standardized templates and structured content formats to enhance submission consistency.
Support initiatives in AI-driven structured content/data management (SCDM) for global regulatory applications.
Collaborate cross-functionally with teams in Quality, Process Development, and Regulatory Affairs.
Stay updated on industry digitalization trends and regulatory innovations.
Contribute to developing and deploying automated data extraction and integration tools.
Train internal teams to build digital fluency within regulatory functions.
Assist in engagements with regulatory agencies around evolving digital and automation standards.
Basic Qualifications:
Doctorate degree OR
Master’s degree with 3+ years of directly related experience OR
Bachelor’s degree with 5+ years of directly related experience
Experience managing or leading a team in a regulatory or compliance setting
Preferred Qualifications:
Degree in life sciences, data science, biochemistry, or chemistry
Experience in global CMC regulatory submissions with working knowledge of ICH and regional guidelines
Exposure to digital transformation initiatives or software development
Background in manufacturing, process development, QA/QC is an asset
Hands-on experience with Veeva Vault or similar regulatory tech platforms
Desirable Attributes:
Strong project management and change management capabilities
Comfort navigating digital innovation in a regulated environment
Ability to translate complex regulatory requirements into digital solutions
Analytical thinker with strong attention to data accuracy and compliance
What You Can Expect from Amgen:
A collaborative, science-driven culture committed to continuous innovation
Competitive compensation and Total Rewards aligned with Indian pharma industry standards
Growth opportunities in both technical and leadership capacities
A chance to shape the digital future of regulatory science in a globally respected biotech company
Estimated Salary: ₹35–48 LPA (based on experience in regulatory affairs and digital transformation)
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