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Regulatory Affairs Specialist (CIS region)

extra parental leave - fully flexible

Remote:

Full Remote

Experience:

Mid-level (2-5 years)

Work from:

Republic of Lithuania

Offer summary

Qualifications:

University degree in Life Science field, Fluent in English, Russian, and resident country languages, 4+ years experience in Regulatory Affairs with medicinal products.

Key responsabilities:

Manage registration activities in EAEU countries
Compile & submit applications for registration
Maintain contact with regulatory authorities & client representative
Participate in SOP creation, Vendors management, and audits

Biomapas Research SME https://www.biomapas.com/

201 - 500 Employees

See more Biomapas offers

Job description

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

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)
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

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

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