Job Description

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..

Requirements:

- Excellent in English - Bachelor degree, Medical Major (Pharmacy, Science ,.... ) - leadership Skills. - Teamwork - Communication Skills - Problem Solving.