Hình đại diện của antonhaptyanov
@antonhaptyanov
Làm thành viên từ 5 tháng 9, 2019
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antonhaptyanov

Trực tuyến Ngoại tuyến
Regulatory affairs expert with over 11 years experience related to obtaining and maintaining of Marketing Authorization of medicinal products, medical devices and cosmetics (including registration, renewal, approval of variations, safety reporting, GMP compliance, preparation of artworks) and clinical trials (including CT start-up, introduction of amendments, Ethics committee reporting and import permissions obtaining for IP and concomitant supplies). Over 8 years managing every step of the medicinal product life cycle from development to after-sales. Providing any types of regulatory consultation in pharma field.
$30 USD/hr
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Trải nghiệm

Head of Registration Department

Dec 2017

Planning, organization, coordination, control and ensuring of effective and in-time regulatory submissions (MA/renewal/variations/PBRER/RMP/DHPC) of registration department, responsible for products stock planning, GMP compliance, artwork process, feasibility research, participation in work groups of pharmaceutical business associations

Senior Regulatory Affairs Specialist

Jul 2015 - Nov 2017 (2 years)

Managed regulatory submissions (registration, renewal, variation) of medicinal products, safety reporting, artwork preparation, stock planning and GMP compliance

Regulatory Affairs Specialist

Jun 2011 - Jul 2015 (4 years)

Managed regulatory submissions (registration, renewal, variation) of medicinal products, safety reporting, artwork preparation, stock planning and GMP compliance

Regulatory Affairs Specialist

Mar 2010 - Jun 2011 (1 year)

Managed regulatory and ethics submissions for initiation of CT, amendments, safety reporting and import licenses

Giáo dục

Master of Science in Pharmacy

2000 - 2005 (5 years)

Xác minh

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