Description
We are looking for a
Global Regulatory Affairs Project Manager (m/f)
Reference: -en
Start: asap
Duration: 12 MM
Place: in Hesse
Branch: Wettbewerber
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
- Management of the regulatory agency interactions, document preparation, co-ordination rehearsals and minutes (under supervision of a TA Head or Regulatory Strategist)
- Participate in 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)
- Excellent spoken and written English
- Experience in Pharmaceutical industry and also Regulatory Affairs
- Experience in preparation and submission of a full submission or large variation/supplement in at least one ICH region through to authorization
Skills:
- Regulatory affairs manager
Keywords: Regulatory Affairs Manager