
Senior Regulatory Compliance Specialist
2 days ago
The ideal candidate for this position will be responsible for overseeing the development and refinement of processes, as well as partnering with colleagues to create systems and tools that enhance the efficiency of operations over time.
This role requires a strong understanding of regulatory compliance and the ability to exemplify the organization's values and leadership attributes. The successful candidate will represent the organization with local stakeholders and ensure a culture of compliance within their team.
Key responsibilities include:
- Managing multiple projects and ensuring timely completion
- Developing solutions to technical and organizational issues
- Fostering a strong team environment
- Managing and developing junior staff
To succeed in this role, the following skills and qualifications are required:
- CMC-specific regulatory knowledge
- Excellent communication and presentation skills
- Ability to work independently and proactively
- Strong computer skills, including word processing, Excel, database/document repository, and project management software
In addition to these skills, the following qualifications are preferred:
- Doctorate degree or Master's/MBA
- Minimum 2/6 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
- Regulatory CMC experience
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