Career Category
RegulatoryJob Description
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.
Knowledge and Skill
- CMC-specific regulatory knowledge & experience with solid working knowledge of product lifecycle changes impacting CTAs and MAs
- Understanding and application of principles, concepts, theories and standards of scientific/technical field
- Experience managing execution of multiple projects
- Knowledge and understanding of different phases of drug development
- Results-oriented and have a track record of completing deliverables on time with high quality
- Excellent communication (both written and verbal), presentation and facilitation skills
- Ability to develop solutions to technical and organizational issues in order to improve performance and productivity
- Ability to work independently and proactively
- Ability to plan, organize and prioritize multiple projects.
- Strong computer skills, including word processing, Excel, database/document repository and project management software
- Ability to influence vertically and across functional boundaries
- Ability to foster a strong team environment, while recognizing the needs of team leaders and key stakeholders
- Manage and develop junior staff
Education and Experience
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
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
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