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
