Regulatory Compliance Team Leader Amgen – Apply Now!
Looking to advance your career in Regulatory Compliance? Amgen, a global biotechnology leader, is hiring a Regulatory Compliance Team Lead (Sr. Manager) in Hyderabad, India. This role requires expertise in Regulatory CMC, Quality, and Biologics Compliance within the pharmaceutical or biotech industry. If you have a strong background in regulatory operations, lifecycle management, and compliance strategy, this is your opportunity to join a world-class team and drive innovation in regulatory affairs. Apply now to become part of Amgen’s mission to transform healthcare!
About Amgen
Amgen is a leading biotechnology company dedicated to the discovery, development, and delivery of innovative human therapeutics. With a focus on areas of high unmet medical needs, Amgen strives to transform new ideas and discoveries into medicines that improve the lives of patients worldwide.
- Job Posting: Regulatory Compliance Team Lead (Sr Manager)
- JOB ID: R-207695
- LOCATION: India – Hyderabad
- WORK LOCATION TYPE: On Site
- CATEGORY: Regulatory
Job 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 the scientific/technical field
- Experience in managing the execution of multiple projects
- Excellent communication (both written and verbal), presentation, and facilitation skills
- Results-oriented with a track record of completing deliverables on time with high quality
- Ability to work independently and proactively
- 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
Education and Experience
Requirements:
- Doctorate degree and 2 years of directly related experience
- Master’s degree and 6 years of directly related experience
- Bachelor’s degree and 8 years of directly related experience
Degree: Life sciences, biochemistry, or chemistry
Experience: Manufacture, testing, or distribution of clinical and/or commercial products, related Quality or Regulatory (CMC) functions in Pharmaceutical/Biotech industry, Regulatory CMC experience, Biologics experience, People management experience.
