(Senior) Regulatory Affairs Specialist Bulgaria at Biomapas

, , Bulgaria -

Full Time

Start Date

Immediate

Expiry Date

11 Mar, 26

Salary

0.0

Posted On

11 Dec, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Affairs, Medicinal Products, Medical Devices, Time Management, Problem Solving, Decision Making, Communication, Translation, Compliance, Documentation, Client Support, Strategic Advice, Operational Advice, Training, Data Reporting

Industry

Research Services

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

Responsibilities

The (Senior) Regulatory Affairs Specialist is responsible for managing registration and post-registration activities for medicinal products and medical devices. This includes communication with local authorities and ensuring compliance with regulatory requirements.