Regulatory Affairs Senior Manager (CMC)

Key Activities

Contributes to product teams and acts as Global RA-CMC lead or supervisor for one or more products. Provides strategic regulatory input and regulatory risk assessments for product teams; executes regulatory strategy with respect to preparation of submissions; complies with critical RA CMC processes; identifies need for process and strategy changes to meet internal Amgen initiatives and changes in external regulatory policy and guidance; reports needs for process changes to CMC systems and contributes to process improvements; incorporates changes in external regulatory guidance into CMC strategy and guidance for product teams; reports issues to RA CMC product team management.

Key Responsibilities Include:

• Oversees deliverables for CMC strategy and submissions for an assigned portfolio of products at varying stages of development,

• Works with external stakeholders including regulatory agencies and influential professional bodies, and seeks to influence regulatory policy globally

• Identifies regulatory risks across products within the defined scope, communicates these risks, and ensures aligned plans for mitigation

• Provides coaching, mentoring, and supports development of junior CMC Regulatory Affairs staff

• Provide CMC regulatory strategy for assigned projects by defining minimal regulatory filing requirements, submission strategy, and regulatory risk assessments

• Develop response strategy and respond to health authority questions

• Liaise with other functions in development, operations and commercial to ensure alignment of global regulatory strategies, timing, execution and supply plans

• Liaise with local regulatory teams to align on filing strategy

• Monitor and, as necessary, provide data to be entered into tracking systems for department deliverables and ensure information is current. Maintain submission information according to the Regulatory Information Management (RIM) system

• Follow established department regulatory processes to ensure cross-product alignment

Knowledge and Skills

Regulatory CMC- specific regulatory knowledge & experience

Staff management and development

Education & Experience (Basic)

Doctorate degreeORMasters degree and 3 years of directly related experienceORBachelors degree and 5 years of directly related experienceORAssociates degree and10 years of directly related experience

Experience in manufacture, testing (QC/QA or clinical), or distribution

Regulatory CMC experience