Regulatory Manager / Senior Regulatory Manager

New

Precision for MedicineClinical Trial Services

Remote, RomaniaFull-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

Bachelors degree, or equivalent experience, in a scientific or healthcare discipline.
5 years Regulatory experience for Manager level; 7 years for Senior Manager level.
Experience working for a CRO or within the Pharmaceutical Industry.
Experience leading Clinical Submissions.
Knowledge of drug development process and regulatory milestones.
Specialised knowledge of regulatory activities for at least one major region (EU, US).
Familiarity with INDs/CTAs, Scientific Advice Procedures, and post-approval submissions.
Ability to understand and interpret clinical and pre-clinical study results.
Knowledge of clinical trials methodology, protocols, and indications.
Proficiency in written and verbal English.
Availability for domestic and international travel.

Provide regulatory guidance throughout the clinical development life cycle.
Compile, coordinate and review applications to Regulatory Authorities including CTA/IND, annual reports, routine amendments, and marketing applications.
Develop and review documents for submission to Regulatory Authorities and/or Ethics Committees.
Serve as representative of Global Regulatory Affairs at project team meetings with both external and internal customers.
Oversee and coordinate Regulatory Affairs Specialists to achieve submission targets.
Maintain project plans, trackers, and regulatory intelligence tools.
Provide input into regulatory strategy and timeline development for new study opportunities.
Provide ICH GCP guidance, advice, and training to internal and external clients.

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