Description
We are looking for a
Regulatory Affairs Project Manager (m/f)
Reference: -en
Start: asap
Duration: 24 MM++
Place: in Hesse
Branch: Wettbewerber
Your tasks:
- Manage and coordinate activities and resources in the entire project life-cycle: initiation, planning, executing, overseeing and closing
- Define for the long term project, intermediate milestones, impact, risk and mitigation plan to avoid project delays and escalation process
- Put in place a structured regulatory roll out plan to oversee "ready to submit dossiers" by product/country, availability of supporting documents, submission and approval within agreed timelines
- Gather project requirements, develop and maintain project documentation
- Act as Regulatory Project Manager counterpart towards representative from the external partner and ensure productive and efficient interactions
- Be part of the Regulatory sub-team, in close collaboration with others team members
- Maintain direct contact with local country RA and external partners to monitor/track submission process
Your qualifications
- Ability to multi-task in fast-paced environment
- Ability to plan and manage a variety of long term projects, control activities and meet deadlines
- Ability to work effectively utilizing problem solving
- Ability to work in teams
- Attention to details
- Experience in pharmaceutical industry
- English skills (business fluent)
- German skills (business fluent)
Skills:
- Regulatory affairs manager
Keywords: Regulatory Affairs Manager