Job description
Join our global team as a (Senior) Regulatory Affairs Specialist.
(Senior) Regulatory Affairs Specialist is responsible for assigned projects and related tasks, supporting local marketing authorization and post-authorization activities, as well as coordinating regulatory activities in other markets, when required.
Position is full-time remote/home-based in Bulgaria.
Responsibilities:
Act as Local Regulatory Affairs Specialist in Bulgaria
Manage registration and post-registration related activities mainly for Medicinal Products (NP, MRP/DCP, CP), as well as providing support for Medical Devices, including, local documents preparation, translation, notification etc.
Maintain timely and effective communication with Local Competent Authorities and client representatives
Regulatory review for AWs, promotional materials, and product information to ensure full compliance with applicable regulatory requirements
Translate/update the specific product dossier documents
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 Biomapas Clients with other RA related tasks, including strategic and operational regulatory advice
University degree in Life Science field
Fluent English language and Bulgarian language
4- 5 years of experience in Regulatory Affairs with medicinal products
Experience in Regulatory Affairs with Medical Devices
Experience with food supplements and cosmetics is advantage
Time management skills
Ability to solve problems and make decisions
Professional growth and career opportunities
International team and environment
Bonus based on annual performance
Personal accident and business trip insurance
Additional health insurance
Remote/home based position with possible visits to HQ
Rewarding referral policy
Workplace establishment allowance
