Description
We are looking for a
Global regulatory affairs project support manager (m/f)
Reference: -en
Start: 01/15
Duration: 12 MM
Place: in Hesse
Branch: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Your tasks:
- Manage the regulatory submission process through to approval, including management and coordination of the preparation of all regulatory documentation at different regulatory milestones
- Manage of the regulatory agency interactions, document preparation, coordinate rehearsals and minutes (under supervision of a TA Head or Regulatory Strategist)
- Contribute to regulatory strategies for projects (under supervision of the Regulatory Strategist)
- Review of protocols, reports and all types of regulatory documentation (quality, safety, efficacy, and labelling) , including CTAs
Your qualifications
- Degree in a Life Science or related discipline, higher degree preferable (PhD, MSc, MBA)
- Experience in CTA requirements WW
- Experience in preparation and submission through to authorization of a full submission/or large variation/supplement in at least one ICH region
- Experience with maintenance of regulatory authorizations in at least one region
- Experience with regulatory agency interactions and preparation of documentation to support interactions
- Experience with supporting a project with development activities in at least two regions
- Knowledge of international regulatory affairs (supported by said experience)
- Knowledge of special consideration opportunities WW
- profound industry experience and regulatory experience
- eCTDs experience
- English business fluent
Skills:
- Regulatory affairs manager
Keywords: Regulatory Affairs Manager