Biomapas
Pharmaceuticals
RegulatoryAffairsSpecialist
Neural analysis suggests this role is
optimal for Entry candidates.
“Regulatory Affairs Specialist at Biomapas. Skills: Regulatory Affairs, Client communication, Authority communication. Regulatory Affairs support for product portfolio. Interactions with authorities”
Industry & Context.
Problems solving skills
Position is full-time remote/home-based in Bulgaria, All CV's must be submitted in English language
What They're Looking For.
Must Have
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, Time-management skills, Good communication skills, Good writing skills, Problems solving skills, Ability to work independently, Ability to work within the team
What You'll Do.
Regulatory Affairs support for product portfolio
Interactions with authorities
Local documents provisions
Procedures management
Systems and databases update
Regulatory Affairs support for affiliate functions
Review advertising and promotional materials
Work according to SOPs
Participate in training
Ensure timely reporting
Updating regulatory data
Support team during audit/inspections
Provision of Regulatory Intelligence
Support Biomapas Clients with RA tasks
How You'll Work.
Team & Collaboration
Support of the team during audit/inspections; Ability to work within the team
Communication Scope
Good communication skills; Good writing skills; Communication with clients; Communication with national authorities
Full Job Description
### 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 poli
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