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 Latvia.
Responsibilities:
- Act as Local Regulatory Affairs Specialist in Latvia.
- 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.
Requirements
- University degree in Life Science field
- Fluent English language and Latvian 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
Benefits
- 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
