Regulatory Affairs Manager

Key Activities

Contributes to product teams and acts as product lead or principal 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:

• Generate and execute of global and country-specific regulatory strategies

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

• Develop global dossiers for CMC content for initial submissions, variations and amendments

• Support change management activities

• 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

CMC- specific regulatory knowledge & experience

Education & Experience (Basic)

Doctorate degree
OR
Masters degree and 3 years of directly related experience
OR
Bachelors degree and 5 years of directly related experience
OR
Associates degree and10 years of directly related experience
OR
High school diploma GED and12 years of directly related experience

Education & Experience (Preferred)

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

Regulatory CMC experience