CMC Regulatory Manager (m/f)

Basel  ‐ Onsite
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Description


We are looking for a
CMC Regulatory Manager (m/f)

Reference: -en
Start: asap
Duration: 6 MM++
Place: in Basel-City
Branch: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen

Your tasks:
  • Support global CMC regulatory teams by writing CMC sections of post-approval marketing applications
  • Establish renewals and answers to deficiency letters
  • Perform regulatory assessment of change controls and discrepancies
  • Support and facilitate review of submissions by collecting comments from the CMC team and reviewers, leading review discussions, and modifying documents
  • Support shareholders (mainly Quality) in term of CMC regulatory oversight


Your qualifications
  • University degree in chemistry, pharmacy, life sciences or equivalent
  • Experience in pharmaceutical CMC regulatory affairs, formulation development, quality, or analytical
  • development is required
  • Experience with post-approval submission is advantageous
  • Detail oriented with excellent interpersonal skills
  • English-language speaking and written skills are required



Skills:
- Regulatory affairs manager
Start date
ASAP
Duration
6 MM++
(extension possible)
From
Hays AG
Published at
17.01.2018
Contact person:
Kerstin Werner
Project ID:
1485398
Contract type
Freelance
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