Regulatory Affairs Manager (m/f)

Hesse  ‐ Onsite
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Keywords

Description


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

Reference: -en
Start: asap
Duration: 24 MM++
Place: in Hesse
Branch: Wettbewerber

Your tasks:
  • Perform regulatory Due Diligence for defined product dossiers and establish gap analysis against country submission content plan for countries in scope
  • Develop and implement appropriate regulatory strategies to ensure successful products submission & approval
  • Act as counterpart towards regulatory contact from the external partner and ensure productive and efficient interactions
  • Define regulatory work package for defined products and coordinate planning of submissions
  • Manage applications for new marketing authorization, answer to questions & any other local request, variations and renewals
  • Adapt dossiers according to company standards and country specific requirements
  • Coordinate the provision of supporting documents with external partner, with regulatory functions and other departments in case of content related issues
  • Review regulatory dossiers and documents (protocols, reports and other types of regulatory documentation) liaising with other regulatory functions as appropriate
  • Maintain direct contact with local country RAs and external partner and monitor the submission process
  • Provide customer and business oriented solutions for problems during submissions
  • Ensure understanding of the external regulatory competitive environment to adapt product regulatory strategy accordingly


Your qualifications
  • Degree in a Life Science or related discipline
  • Experience with LCM activities in at least two regions (e.g. Europe, LATAM, APAC)
  • Experience in pharmaceutical industry
  • Prior experience in performing regulatory due diligence
  • English skills (business fluent)
  • German skills (business fluent)



Skills:
- Regulatory affairs manager


Keywords: Regulatory Affairs Manager
Start date
ASAP
Duration
24 MM++
(extension possible)
From
Hays AG
Published at
22.10.2014
Contact person:
Kerstin Werner
Project ID:
795465
Contract type
Freelance
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