Больше информации по резюме будет доступно после регистрации
ЗарегистрироватьсяCandidate
Male, 41 year, born on 7 November 1983
India, not willing to relocate, not prepared for business trips
Pharmaceuticals Regulatory affairs
Specializations:
- Medical representative
Employment: full time, project work
Work schedule: full day, shift schedule, rotation based work
Work experience 4 years 1 month
August 2011 — August 2015
4 years 1 month
India, www.accenture.ru
IT, System Integration, Internet... Show more
Subject Matter Expert
Handling of Insight Manager®, eDossier®, Adobe Acrobat Pro, FirstDoc®. ISI Tool Box.
Generating copies of registration documents for submission to different agencies and Authority
of USFDA and MHRA, TPD, EDQM.
Submission Coordination for Regulated markets.
Preparation of letter of access based on the requirements of Marketing
Preparation of Technical package Send to the Customer
Customer query Response regarding deficiency in DMF
Document compilation For USA and Europe Market As per ICH Q7 Guideline in CTD Format
Administration supporting work related to Regulatory affairs Department
Skills
Skill proficiency levels
About me
I am a seasoned professional with seven years of experience in Regulatory domain. My core
expertise is in query response to deficiency in DMF, Dossier compilation, electronic publishing, and
registration of documents for submission in EU and ROW countries. At present I am a team leader who
resolves, directs, and motivates the team to achieve objectives and deliverables to set standards laid down by
the company
Higher education (bachelor)
2005
University of Mysore
Lifesciences, Biochemistry
Languages
Citizenship, travel time to work
Citizenship: India, Russia
Permission to work: Russia
Desired travel time to work: Doesn't matter