Regulatory Affairs Manager

• Set submission strategy & Leading functionally the regulatory affairs departments in the region.
• Lead the preparation of regulatory documents/files required for new registration and Re-registration product maintenance (line extensions, variations, license renewals) and responses to Health Authority queries.
• Ensure that all the above RA documents/files are complied with the most recent regulations and being provided to distributor and or Health authority in challenging time frame to meet local RA plans/objectives.
• Keep up-to-date knowledge on regulatory legislation and requirements.
• Develop, write and update, as appropriate, RA document that encompasses all regulatory requirements/ legislations in countries to act as guidance and road map for management.
• With shared accountability and cross-functional teamwork together provide expert opinion to management in regards to new product development, portfolio management, and product approval.
•  Support local and global Commercial, Business Development, Supply chain and Regulatory Affairs departments with registration and launch strategies for upcoming and ongoing products registrations.
• Following up with different NODCAR departments, Registration and inspection.
• Keeping an excellent relation with MOH stakeholder in Egypt.
• Managing any product complaint with Health authority.

job requirements

10 to 15 years

Not Specified