Only 24h Left) Regulatory Compliance Team Lead

3 weeks ago

Hyderabad, Telangana, India Amgen Inc Full time
Job Description

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 managing the execution of multiple projects.
- Knowledge and understanding of different phases of drug development.
- Results-oriented with 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 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 the manufacture, testing, or distribution of clinical and/or commercial products or related Quality or Regulatory (CMC) functions in the Pharmaceutical/Biotech industry.
- Regulatory CMC experience.
- Biologics experience.
- People management experience.

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