Join our global team as a Regulatory Affairs Specialist.
Regulatory Affairs Specialist is responsible for assigned project and related tasks, applications and dossiers submissions, communication with clients and national authorities.
Position is full-time remote/home-based in Bulgaria.
All CV's must be submitted in English language for the assessment.
Responsibilities:
- Regulatory Affairs support for the dedicated product portfolio (MP, MD, FS, cosmetics) including interactions with authorities, local documents provisions, procedures management, artwork, PI update, translations, systems and databases update
- Regulatory Affairs support for the other affiliate functions
- Review of advertising and promotional materials regarding regulatory compliance
- Work according to the standard operating procedures provided by Biomapas/Client, follow updates and participate in the training
- Ensure timely reporting and updating of regulatory data within Client systems.
- Support of the team during audit/inspections
- Provision of Regulatory Intelligence
- Support Biomapas Clients with other RA related tasks, including strategic and operational regulatory advice.
Requirements
- University degree in Life Science/Pharmaceutically related science (Chemistry, Pharmacy, Biochemistry, Biology, Medical Engineering) field
- Fluent English language and Bulgarian language
- 2 years experience in Regulatory Affairs with medicinal products, medical devices, food supplements and cosmetics
- Attention to detail and time-management skills
- Good communication and writing skills
- Problems solving skills, ability to work independently and within the team
Benefits
- International team and environment
- Professional growth and career opportunities
- Bonus based on annual performance
- Additional bonus system – Instant reward and Recognition program
- Personal accident and business trip insurance
- Additional health insurance
- Influenza vaccines
- Rewarding referral policy
- Workplace establishment allowance