Regulatory Affairs Specialist Bulgaria

Join our global team as a Regulatory Affairs Specialist.

Regulatory Affairs Specialist is responsible for assigned projects and related tasks, applications and dossiers submissions, communication with clients and national authorities.

Position is remote/home-based in Bulgaria. Part time role – 0,5 FTE.

Responsibilities:

• Manage registration related activities mainly for Bulgaria and EU
• Compile and submit applications for registration, renewals, variations in accordance to the national and EU legislation
• Maintain contact with regulatory authorities, client representative
• Make regulatory monitoring of the current duties related with particular product
• Participate in audits
• Translate/update the specific product dossier documents
• Update/collect information on registration instructions and regulations

Requirements:

• University degree in Life Science field
• Fluent English language and Bulgarian language
• 3-4 years experience in Regulatory Affairs with medicinal products
• Experience in Regulatory Affairs with Medical Devices
• Experience with medical devices, food supplements and cosmetics is advantage
• Time management skills
• Ability to solve problems and make decisions

Benefits of being a part of our team:

• Professional growth and career opportunities
• Supportive work environment
• Additional benefits
• Remote work

 

Job Category: Regulatory Affairs
Job Type: Part Time
Job Location: Bulgaria

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Big Enough To Cover  All Your Needs. Small Enough To Care. 

Meeting timelines and milestones is critical to move your development program forward while keeping the goal in mind. Our in-house experience combined with a hands-on mindset allows for tailored solutions to complicated challenges that emerge on your path to commercialization.

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