Job Description
- Guarantee consistence of Maghreb group exercises with neighborhood and local pharma guideline (limited time and non special exercises identified with results of duty)
- Leads and executes readiness, accommodation and exchange of endorsement for Maghreb administrative entries, including content/structure definition, arrangement/survey/accumulation of segments, tests requesting and accommodation, and accommodation audit. Goes about as essential contact with Health Authorities for alloted items.
- Team up with Global Regulatory Affairs for required archives
- for planning of administrative dossiers
- Drive "Idea to Commercialization approach" and guarantee total responsibility "forever cycle upkeep" - (Includes Registration, Renewals, Change Control, Variation documenting, naming consistence, delicate help) and auspicious execution all things considered.
- Give evaluation of the effect of new and changing guidelines/prerequisites in important nations in Maghreb.
- Plan (as required) and audit key application parts and meeting materials and seat/go to gatherings with administrative organizations and different partners.
- Guarantee proper assessment of nearby business and administrative enlistment necessities for research and showcased items and plan administrative evaluation reports as required.
- Communicate with merchants in the pertinent nations; specialist co-ops and administrative organizations to determine related issues inquiries to be routed to
- the relegated tasks and the interface with key corporate practical regions
- Bolster the RA Regional Head Maghreb on explicit undertakings as mentioned
- Survey and guarantee auspicious endorsement of limited time and non-special material in Maghreb.
Key Skills, Abilities, and Competencies
- Experience of submitting enrollment dossiers for new items, Renewals, varieties in Maghreb area (Algeria +++)
- Comprehension of pertinent Maghreb nearby guidelines in taking care of Biological, Biotech and vagrant medications (liked)
- Venture the executives capacities: High feeling of association, performs multiple tasks, results arranged, regard of due dates, cross-usefulness
- Partner the board
- Ready to create successful working associations with HAs/MoH
- Capacity to think deliberately and fundamentally assess dangers to administrative exercises.
Company Profile:
Salary: Not disclosed
Industry: Pharma / Biotech / Medical research
Functional Area: Quality control regulatory
Role Category:
Employment Type: Full time
Keyskills
