Job Description

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