Amgen - Senior Manager - Regulatory Affairs - Data Automation

Job Title : Senior Manager, Regulatory Affairs CMC - Data Automation-

Job Summary:

Amgen is seeking a Senior 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:

- Lead the development and implementation of automation strategies to support regulatory CMC filings.

- Provide subject matter expertise in CMC automation, including guidance on regulatory strategy, AI and SCDM applications, and industry best practices.

- Collaborate with internal stakeholders (Process Development, Quality, Global Regulatory Affairs & Safety, R&D Policy) and external partners to drive AI and automation initiatives.

- Contribute to Amgen's internal CMC Authoring Automation initiatives, focusing on SCDM and generative AI applications for regulatory use cases.

- Influence regulatory strategy by leveraging external intelligence, industry trends, and evolving guidance on AI and data automation.

- Develop and deliver training programs to enhance internal expertise on automation and AI-driven regulatory filings.

- Support cross-functional alignment on regulatory engagement strategies related to emerging technologies and digital transformation.

- Advocate for regulatory innovation by participating in external forums and initiatives.-

- Foster a culture of learning and active participation within the RA-CMC team, sharing best practices and regulatory insights.

- Develop and refine standardized templates for structured data capture, ensuring seamless data conversion from unstructured sources.

- Define mappings between source systems, narrative templates, and FHIR standards to ensure compliance and accuracy.

- Design and deploy automated data extraction and conversion solutions to streamline regulatory documentation and submission execution.

Basic Qualifications:

- Doctorate degree and 2 years of directly related experience OR Master's degree and 6 years of directly related experience OR Bachelor's degree and 8 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

- Proven leadership experience in managing teams and training staff

- Hands-on experience with Veeva Vault platforms and regulatory technology solutions

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