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Κατηγορία

Περιοχή

Απασχόληση

Εταιρία:
GENEPHARM ΑΕ
Ημερομηνία Δημοσίευσης:
16-01-20
Τύπος απασχόλησης:
Πλήρης
Κωδικός θέσης εργασίας:
RA/2020
Κατηγορία εργασίας:
Υγεία
Επιστήμες
Περιοχή εργασίας:
Νομός Αττικής

Regulatory Affairs Officer

Genepharm S.A., a Leading European Generic Pharmaceutical Company,
with an impressive international customer base, seeks to appoint:

Regulatory Affairs Officer

(REF: RA/2020)

The position resides within the Regulatory Affairs Department and it involves new and marketed products support as it pertains mainly to writing, compiling, and maintenance of the administrative, quality and technical sections.

The candidate is expected to remain current with regards to regulations, guidelines and policies for the pharmaceutical/manufacturing areas and to assist in interpreting and advising on the complex and evolving regulatory requirements.

Major responsibilities include, but are not limited to, the following:

  • Coordinating, compiling and reviewing CMC (quality) data package for appropriate and complete documentation
  • Communicating with internal and external parties to obtain required supporting documents data for compilation of the CTD dossier, supplements/variations, responses to authorities’ questions etc., maintaining timelines of projects
  • May provide regulatory / CMC expertise during negotiations and interactions with regulatory agencies

The applicant should have:

  • At least bachelor’s degree in Pharmacy, Chemistry or related scientific discipline preferable with minimum 3 years Regulatory Experience in similar position or in R&D department
  • Excellent knowledge of English both written and oral
  • Be able to handle multiple tasks/projects, meeting deadlines

The Company offers:

  • Competitive Salary
  • Training and development opportunities

Candidates who believe they meet the above requirements are invited to send their CV in English to the address:
GENEPHARM S.A., 22C Marathon Avenue, 19009 Pikermi, Fax: 210.60.39.402 or via e-mail

[To send your CV please click here]

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