September, 29th

Regulatory Affairs Non-EU Submissions Project Manager

RA_Non EU
PREV. JOB

Role and Responsibilities

• Support, planning and coordination of all activities needed for the RoW registration process of pharmaceutical products developed by PharOS according to local requirements
• Communication with clients for the preparation of the documentation needed for submission and approval of Marketing Authorization Applications, variation and renewal procedures in RoW
• Design of Global regulatory strategies for submissions in RoW based on local national requirements.
• Participation in Tcons with clients
• Participation in kick-off meetings for strategic clients

Experience & Qualification

• Degree holder in Life sciences: Pharmacy, Biology, Chemistry or similar scientific disciplines
• At least 2 years’ experience in Non-EU regulatory submissions
• Good knowledge of regulations, guidelines and procedures relating to registration of pharmaceutical products worldwide.
• Excellent English oral communication and scientific writing skills
• PC literacy (word, excel, ppt etc)
• Excellent organizational, project management and problem-solving skills, team working spirit
• Oriented to focus on detail
• Ability to deliver under specific deadlines
• Communicate effectively both internally and externally

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