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Essential Functions:
- Provides regulatory guidance throughout the clinical development life cycle
- Compile, coordinate and review applications to Regulatory Authorities
- Provides strategic regulatory input as required
Qualifications:
- Bachelors degree, or equivalent experience, ideally in a scientific or healthcare discipline
- 5 years Regulatory experience required for the Manager level and 7 years Regulatory experience required for the Senior Manager Regulatory level
- Candidates must have regulatory affairs experience working for a Clinical Research Organisation
Competencies:
- Strong interpersonal skills and a proven ability to contribute to a team environment
- Ability to manage multiple and varied tasks in a fast-moving environment, good record-keeping skills
- Communicates effectively in the English language both verbally and in written form
Precision for Medicine
Precision for Medicine integrates clinical trial execution with scientific knowledge, lab expertise, and data science to improve the speed, cost, and success rate of life-changing therapies. They focus on Oncology and Rare Disease and value employee contributions.