Preparation of submission documents for the registration of the Biotech products in local and international markets (including MENA, LATAM, North Africa, Asia)
Ensure timely registration of products in compliance with applicable regulation and guidelines.
Work collaboratively with countries Project Leaders to identify documents that require submission
Expedite and coordinate a multitude of interrelated activities for a submission team in the development of published submission within the required timelines.
Facilitate documents exchange for translation
Track metrics associated with submission planning and publishing reports & template for info
Plan and conduct cross-functional meeting
Requirements:
Min. Bachelor Degree in Pharmacy, Chemistry or Biology, master science in biotechnology is preferable.
Min. 3 years in the pharmaceutical or biopharmaceuticals regulatory affairs positions
Excellent command of Microsoft Office applications,
Ability to effectively communicate and influence others across functions
Ability to organize and lead project teams
Meticulous and detail-oriented
Able to start work immediately or within short notice