Regulatory Affairs Manager OTC

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Location
Contract Type
Full-time
Salary
70 000 - 90 000 Kč
Published
Reference
19-13-383567
This position is archived.
This position is archived.
Job description

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
Requirements
  • 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
Benefits
  • 6 weeks vacation
  • 12 sick days
  • 2 charity days
  • Meal vouchers 120 CZK/day
  • Bonus
  • Multisport card
  • Notebook, mobile
  • Pension & Life insurance
Other notes
For more related job opportunities visit https://www.grafton.cz/en/job-search
This position is archived.
This position is archived.