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Manager, Regulatory Affairs/Regulatory Affairs Specialist
Eingestellt von Real Staffing Group aus Frankfurt am Main
Projektbeschreibung
The role will be responsible for managing regulatory activities in both foreign and domestic markets. The right candidate should be able to hit the ground running, and have both preclinical and clinical RA strategy.
RESPONSIBILITIES:
-Preparation and coordination of regulatory submissions for marketed products
-Coordinate INDs, NDAs, renewals, labelling updates and variations.
-Liaises with company affiliates and third parties to coordinate a variety of activities
-Communicate regulatory strategy to project teams for assigned products
-Liaises with regulatory, manufacturing and other parties as appropriate
-Lead regulatory team meetings
-Plan, prepare, and track, submissions to regulatory agencies.
SKILLS REQUIRED:
* Bachelor's degree in a relevant discipline
*Proven significant experience in Regulatory Affairs.
*Experience in the submission of regulatory documentation
*Direct experience working with Regulatory Authorities
*Excellent organization skills and ability to multi-task
*Ability independently manage workload
To find out more about Real Staffing please visit www.realstaffing.com
Projektdetails
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Einsatzort:
Virginia, Vereinigte Staaten
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Projektbeginn:
asap
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Projektdauer:
Keine Angabe
- Vertragsart:
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Berufserfahrung:
Keine Angabe
Geforderte Qualifikationen
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Kategorie:
Sonstiges