Regulatory Compliance Team Lead (Sr Manager)

The Regulatory Compliance Team Lead will be responsible for overseeing a team of regulatory CMC professionals performing assessment of operational changes for regulatory reportability for Amgen products across phases of development, modality, and countries. This role is accountable for hiring, training and retaining talented regulatory CMC regulatory staff, in alignment with the operational objectives of the wider RA CMC department. They are accountable for continuous improvement, through the development and refinement of processes, and partnership with colleagues in other functions to develop systems and tools that improve the speed and efficiency of operations over time. They exemplify the Amgen values and leadership attributes, represent Amgen with local stakeholders and ensure a culture of compliance within the team. The ideal candidate should possess CMC-specific regulatory knowledge & experience with solid working knowledge of product lifecycle changes impacting CTAs and MAs. They should have an understanding and application of principles, concepts, theories and standards of the scientific/technical field. Experience in managing the execution of multiple projects is essential. A good knowledge and understanding of different phases of drug development is required. The candidate must be results-oriented with a track record of completing deliverables on time with high quality. Excellent communication (both written and verbal), presentation and facilitation skills are necessary. The ability to develop solutions to technical and organizational issues in order to improve performance and productivity is crucial. The candidate should be able to work independently and proactively, with the ability to plan, organize and prioritize multiple projects. Strong computer skills, including word processing, Excel, database/document repository, and project management software are essential. The candidate should have the ability to influence vertically and across functional boundaries and foster a strong team environment, while recognizing the needs of team leaders and key stakeholders. Managing and developing junior staff is also a key responsibility. Education and Experience requirements include: - Doctorate degree and 2 years of directly related experience - OR Masters degree and 6 years of directly related experience - OR Bachelors degree and 8 years of directly related experience - Degree in life sciences, biochemistry, or chemistry - Experience in manufacture, testing, or distribution of clinical and/or commercial products or related Quality or Regulatory (CMC) functions in Pharmaceutical/Biotech industry - Regulatory CMC experience - Biologics experience - People management experience,