We are seeking a Regulatory Compliance Change Assessor to interface with global, site, biosimilars, and device regulatory teams, as well as Amgen Operations, Quality, and Supply Chain. This role is responsible for the global reportability assessment of single or cross-product changes, ensuring that all product-related changes adhere to regulatory requirements. The ideal candidate will have extensive experience in regulatory CMC within the pharmaceutical or biotechnology industry.
Roles & Responsibilities
- Change Assessment: Review change records to evaluate the impact of changes with respect to reportability and product restrictions. You will define and document the reporting and product distribution restriction requirements within the change control management system.
- Strategic Alignment: Liaise with various functions, including Process Development, Operations, Quality, and Supply Chain, to ensure alignment of regulatory strategies. You will provide expertise and guidance to interdepartmental and cross-functional teams.
- Leadership & Mentorship: Coach and support junior regulatory staff in their career development.
- Process Improvement: Identify and implement process improvements for the change management process.
Technical Skills
- Strong regulatory CMC specific knowledge and experience.
- Understanding and application of principles, concepts, and standards in a scientific or technical field.
- Experience in manufacture, testing (QC/QA or clinical), or distribution within the pharmaceutical or biotech industry.
Qualifications
- A Doctorate degree, a Master's degree with relevant experience, a Bachelor's degree with extensive experience, or a Diploma with a substantial background in manufacturing, QA/QC, or regulatory CMC in the pharmaceutical/biotechnology industry.
- A degree in a Life Science discipline is preferred.
