Biomapas
Local Regualtory Affairs Specialist in Romania (Freelance/ 0.1 FTE)
RomaniaRemotePosted 3 days ago
Full TimeRemoteRO
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Job Description
Freelance opportunity in Romania! Join our global team as a Local Regulatory Affairs Specialist in Romania.Local Regulatory Affairs Specialist will be responsible for ensuring that medicinal and other
Key Highlights
- Act as Local Regulatory Affairs Specialist in the assigned territory.
- Oversee and manage all local Regulatory Affairs activities related to Medicinal Products (MP), Medical Devices (MD), and Food Supplements (FS), ensuring full compliance with applicable regulatory framework.
- Maintain timely and effective communication with local Competent Authorities.
- Monitor and report changes in national regulatory requirements on a regular basis.
- Develop and/or review of regulatory strategy to support product lifecycle planning, including initial market entry and post-approval changes.
Qualifications
Required Qualifications
- Biologist, Pharmacist, Medical Doctor, or other life science degree
- Fluent written and spoken English and Romanian
- At least 2 years of experience in local regulatory affairs activities
- Proven experience managing local Regulatory Affairs activities in Romania for MP, MD and FS
- Experience with local documents preparation and regulatory submissions
- Excellent knowledge of local and international regulations
- High motivation to develop and learn within the team
About the Company
Biomapas
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Job Details
Employment Type
Full Time
Location
Romania
Work Mode
Remote
Posted
3 days ago
Country
RO