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Biomapas

(Senior) Regulatory Affairs Specialist Bulgaria

full-time Remote

AI overview

Manage regulatory activities for Medicinal Products and Medical Devices, ensuring compliance and effective communication with Local Competent Authorities while supporting clients.

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

Requirements

  • 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

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

Perks & Benefits Extracted with AI

  • Health Insurance: Additional health insurance
  • Rewarding referral policy: Rewarding referral policy
Biomapas

Biomapas is a functional and full outsourcing solution provider to the global life science industry. As a trusted partner for biopharmaceutical, medical device, cosmetics, and food supplement companies, we have one-stop-shop clinical research capabilities in high recruiting countries, delivering regulatory and pharmacovigilance excellence across Europe, CIS, MENA, and LATAM regions through the entire product lifecycle. Our in-house experience combined with a hands-on mindset allows for tailored solutions to complicated challenges that emerge on your path to commercialization. Our professionals execute your projects efficiently, cost-effectively and aspire to partner with you and become an integral part of your team from Early Development to Commercial success.

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