Local Regulatory Affairs Specialist
New
B
BiomapasRegulatory Affairs
RomaniaPart-TimeMiddle
Salary not disclosed
Apply NowOpens the employer's application page
Job Details
- Languages
- English, Romanian
- Experience
- At least 2 years of experience in local regulatory affairs activities
Requirements
- Degree in Biology, Pharmacy, Medicine, or other life science field.
- 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.
Responsibilities
- 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.
- Prepare regulatory documentation for submission to Competent Authorities.
- Regulatory review for labelling components, promotional materials, and product information.
- Translations and proofreading.
- Ensure accurate documentation, reporting, and follow-up of all regulatory reports.
- Support Biomapas Clients with other RA-related tasks, including strategic and operational regulatory advice.
View Full Description & ApplyYou'll be redirected to the employer's site
