Regulatory Manager / Senior Regulatory Manager
P
Precision for MedicineLife Sciences, CRO
Remote, United KingdomFull-TimeManager
Salary not disclosed
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Job Details
- Languages
- English
- Experience
- 5 years Regulatory experience required for the Manager level and 7 years Regulatory experience required for the Senior Manager Regulatory level
- Required Skills
- Project Management
Requirements
- Bachelor's degree in a scientific or healthcare discipline, or equivalent experience.
- Minimum 5 years of regulatory experience for Manager level, 7 years for Senior Manager.
- Proven experience working for a CRO or within the Pharmaceutical Industry.
- Demonstrated experience leading Clinical Submissions.
- In-depth knowledge of drug development regulatory milestones and processes.
- Specialized knowledge of regulatory activities in at least one major region (EU or US).
- Understanding of clinical trials methodology, including protocols and study indications.
- Ability to interpret clinical and pre-clinical study results for regulatory strategy.
- Proficiency in English, both verbal and written.
- Ability to conduct formal presentations to diverse audiences.
- Availability for domestic and international travel including overnight stays.
Responsibilities
- Provide regulatory guidance throughout the clinical development life cycle.
- Compile, coordinate, and review applications to Regulatory Authorities including CTA/IND, annual reports, and marketing applications.
- Develop and review documents for submission to Regulatory Authorities and Ethics Committees to ensure compliance.
- Represent Global Regulatory Affairs at internal and external project team meetings.
- Oversee and coordinate Regulatory Affairs Specialists to achieve submission targets.
- Maintain project plans, trackers, and regulatory intelligence tools.
- Provide regulatory strategy and timeline input for new study opportunities.
- Provide ICH GCP guidance and training to internal and external clients.
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