Regulatory Affairs Manager OTC

Lokalita
Druh pozice
Plný úvazek
Mzda
70 000 - 90 000 Kč
Zveřejněno
Kontaktní osoba
Referenční číslo
19-13-383567
Tato pozice je archivovaná
Tato pozice je archivovaná
Popis pozice

Do you see yourself being part of multinational pharmaceutical company where you can use your experience in Regulatory area?

Do you have experience with OTC, MD or cosmetics?

Great opportunity is here!

Regulatory Affairs Manager:

  • submission of labelling, quality changes (CCDS according to SOP)
  • applications for new marketing authorization, translations of product information
  • monitoring of the submission status with the authorities
  • ensuring productlabeling is in-line with CZ and SK requirements (OTC, cosmetics, MD))
  • submission of needed documents to health authorities (also being its contact person)
  • updating of internal and external databases and document management systems (like BRAIN, Synaps, local compendia, etc.)
  • colaborating with other region (SK) with development and marketing process by providing regulatory advice to internal partners
  • liaison with authorities, global RA and local Medical Department
  • ensuring compliance with all relevant global and local codes of practice
Požadavky
  • scientific degree or other relevant qualification (Pharmaceuticals, chemistry or similar)
  • experience in Regulatory Affairs (min. 2 years)
  • ENG language (B2/C1) everyday use)
  • good organizational & communication skills (adequate negotiating, interpersonal and influencing skills)
  • knowledge of national and European pharmaceutical regulatory requirements
  • commercial awareness and a good scientific knowledge of the therapeutic areas
  • ability to learn and maintain knowledge of a technologically and legally complex area
Benefity
  • 6 weeks vacation
  • 12 sick days
  • 2 charity days
  • Meal vouchers 120 CZK/day
  • Bonus
  • Multisport card
  • Notebook, mobile
  • Pension & Life insurance
Další informace
Více podobných pozic naleznete na https://www.grafton.cz/cs/job-search
Tato pozice je archivovaná
Tato pozice je archivovaná