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
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. We keep our promises. Always. Social media privacy policy: bit.ly/privacy-biomapas
Key team members
Tomaz Trcek
Martijn van de Leur
Valdis Tocs
Inga Garliauskiene
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