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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.
Job Requirements
- Bachelor degree of Pharmaceutical science.
- 10 + years of experience in RA management.
- Communication & Negotiation skills.
- Leadership & Management skills.
- Problem Solving & decision -making skills.
- Analytical Thinking.
- Result- oriented.
