6 Π΄Π½Π΅ΠΉ Π½Π°Π·Π°Π΄
Experienced RA Professional Lifecycle Submissions EM
ΠΡΡΡ & Π‘ΠΎΠΏΡΠΎΠ²ΠΎΠ΄
ΠΠ»Ρ ΠΌΡΡΡΠ° Ρ ΡΡΠΎΠΉ Π²Π°ΠΊΠ°Π½ΡΠΈΠ΅ΠΉ Π½ΡΠΆΠ΅Π½ Plus
ΠΠΏΠΈΡΠ°Π½ΠΈΠ΅ Π²Π°ΠΊΠ°Π½ΡΠΈΠΈ
Π’Π΅ΠΊΡΡ:
TL;DR
Experienced RA Professional Lifecycle Submissions EM (Regulatory Affairs/Pharmaceuticals): Coordinating end-to-end lifecycle management procedures and preparing regulatory submissions for emerging markets with an accent on country-specific requirements, submission quality, and timely implementation. Focus on proposing national procedure strategies, managing health authority approvals, updating regulatory databases, and monitoring risks and timelines across the MAFSA region.
Location: Hybrid position in Casablanca, Morocco
Company
Global healthcare organization developing innovative medicines and MedTech solutions across the full spectrum of patient care.
What you will do
- Coordinate end-to-end lifecycle management procedures for the MAFSA region and other emerging markets.
- Propose national procedure strategies and timelines to local operating companies and coordinate with regional regulatory stakeholders.
- Prepare submission-ready documents and high-quality response dossiers for health authorities.
- Process health authority approvals and ensure timely implementation of post-approval activities.
- Maintain regulatory databases and monitor lifecycle activities, escalating delays and risks when needed.
- Contribute to process improvement initiatives and implementation of new regulatory requirements, tools, and systems.
Requirements
- Fluency in French, English, and Arabic.
- At least 3 years of experience in pharmaceutical regulatory affairs.
- Experience with regulatory activities, submissions, and country-specific requirements.
- Ability to conduct risk assessments and work under moderate supervision.
Culture & Benefits
- Inclusive work environment focused on individual dignity, diversity, and merit.
- Collaboration with local, regional, global, and external regulatory stakeholders.
- Opportunity to support treatments and healthcare solutions across emerging markets.
ΠΡΠ΄ΡΡΠ΅ ΠΎΡΡΠΎΡΠΎΠΆΠ½Ρ: Π΅ΡΠ»ΠΈ ΡΠ°Π±ΠΎΡΠΎΠ΄Π°ΡΠ΅Π»Ρ ΠΏΡΠΎΡΠΈΡ Π²ΠΎΠΉΡΠΈ Π² ΠΈΡ ΡΠΈΡΡΠ΅ΠΌΡ, ΠΈΡΠΏΠΎΠ»ΡΠ·ΡΡ iCloud/Google, ΠΏΡΠΈΡΠ»Π°ΡΡ ΠΊΠΎΠ΄/ΠΏΠ°ΡΠΎΠ»Ρ, Π·Π°ΠΏΡΡΡΠΈΡΡ ΠΊΠΎΠ΄/ΠΠ, Π½Π΅ Π΄Π΅Π»Π°ΠΉΡΠ΅ ΡΡΠΎΠ³ΠΎ - ΡΡΠΎ ΠΌΠΎΡΠ΅Π½Π½ΠΈΠΊΠΈ. ΠΠ±ΡΠ·Π°ΡΠ΅Π»ΡΠ½ΠΎ ΠΆΠΌΠΈΡΠ΅ "ΠΠΎΠΆΠ°Π»ΠΎΠ²Π°ΡΡΡΡ" ΠΈΠ»ΠΈ ΠΏΠΈΡΠΈΡΠ΅ Π² ΠΏΠΎΠ΄Π΄Π΅ΡΠΆΠΊΡ. ΠΠΎΠ΄ΡΠΎΠ±Π½Π΅Π΅ Π² Π³Π°ΠΉΠ΄Π΅ β