Biomapas is hiring a
Regulatory Affairs Specialist

Summary

The Regulatory Affairs Specialist will manage registration activities in the EAEU Member States and resident country, compile and submit applications for registration, maintain contact with regulatory authorities, and participate in audits. The ideal candidate should have a university degree in Life Science field, fluent English, Russian, and resident country languages, at least 4 years of experience in Regulatory Affairs with medicinal products, and 3 years of experience under the EAEU procedures. Benefits include professional growth opportunities, international team environment, bonus based on annual performance, personal accident and business trip insurance, additional health insurance, remote/home-based work, influenza vaccines, a rewarding referral policy, workplace establishment allowance (for fully remote workers), team building events, and global meetings.

Requirements

• 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)

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

Preferred Qualifications

• An additional advantage is experience in all EAEU countries
• Experience with medical devices, food supplements and cosmetics is advantage

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
• Influenza vaccines
• Rewarding referral policy
• Workplace establishment allowance (fully remote)
• Team building, global meetings, B active events