Regulatory Affairs Specialist (CIS region)

Join our global team as a Regulatory Affairs Specialist in CIS region.

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

Responsibilities:

• Manage registration related activities in the Member States of the EAEU (for common procedures) and resident country (for national procedures)
• Compile and submit applications for registration, renewals, variations in accordance to the common rules of the EAEU
• Drafting a normative document, creating an eCTD, readability user testing in accordance to the common rules of the EAEU
• Compile and submit applications for registration, renewals, variations in accordance to the national legislation
• Maintain contact with regulatory authorities, client representative
• Participate in Standard Operating Procedures creation
• Vendors management
• Participate in audits

• University degree in Life Science field
• Fluent English, Russian and resident country languages
• At least 4 year’s experience in Regulatory Affairs with medicinal products
• 3 years of experience in Regulatory Affairs with medicinal products under the EAEU procedures (both in the reference country and in the countries of recognition)
• An additional advantage is experience in all EAEU countries
• Experience with medical devices, 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
• Influenza vaccines
• Rewarding referral policy
• Workplace establishment allowance (fully remote)
• Team building, global meetings, B active events

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