Manager, Regulatory Affairs
New
J
JobgetherClinical Research
RomaniaFull-TimeManager
Salary not disclosed
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Job Details
- Languages
- English
- Experience
- Minimum 5–7 years of experience within the pharmaceutical or CRO industry
- Required Skills
- Project ManagementBusiness DevelopmentMentoringStakeholder management
Requirements
- Bachelor's degree in a medical, biological, physical, health, or pharmacy-related scientific discipline.
- Alternatively, a two-year degree with at least eight years of clinical research experience.
- Minimum 5–7 years of experience within the pharmaceutical or CRO industry.
- Proven senior-level regulatory affairs or clinical start-up experience.
- Strong understanding of ICH GCP and country-specific regulations.
- Demonstrated leadership, strategic thinking, and planning skills.
- Excellent written and verbal English communication skills.
- Ability to manage multiple priorities and meet deadlines in a fast-paced environment.
- Experience with business development, including contract negotiations and proposal preparation.
Responsibilities
- Lead and coordinate regulatory and ethics committee submissions across EMEA, Asia Pacific, and Latin America.
- Ensure regulatory submissions are accurately compiled, managed, tracked, and maintained.
- Provide expert regulatory guidance throughout clinical research projects.
- Review technical and study documentation including IMPDs and IBs.
- Communicate submission status and risks with sponsors and project teams.
- Support business development activities by reviewing study budgets and contributing to proposals.
- Train, coach, and mentor junior regulatory affairs professionals.
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