Job description
Scope & ِAccountabilities ِ
Ensure registration activities of planned/registered products. Provide high quality strategic guidance, regulatory information/ expertise in a timely fashion and support the business objectives in line with Leo Pharma Mission and Ethical Standards
Tasks & Responsibilities
- Ensure execution ofregulatory activities in Egypt:
o Assist with Regulatory activities so that the company’s regulatory and statutory requirements are met on time and within regulatory strategic requirements
o Support the administrative activities in preparing packages for registration, renewals, variation and analysis files in a timely submission manner under instructions
o Ensure that the registration, renewals, variation and analysis files are completed with the information required by the Health Authorities and guidelines provided.
o Ensure timely submission and approval of files by monitoring progress of results of the Regulatory Manager
- Contribute in sustaining marketable products in terms of compliance with the regulatory framework
- Assist with specific labelling activities as per instructions
o Ensure optimal product labelling and timely implementation of new and/or revised labelling text for packaging material through updates in collaboration with Regulatory employees within the Area of responsibility.
o Review of promotional materials and coordinate with marketing department for the review before final approval.
o Perform other ad hoc tasks/projects as decided and agreed by the Regulatory Affairs Manager
o Create summary reports related to Registrations, Renewals and Variations for the RA Manager, to ensure Regulatory compliance and reporting needs
- Report to the RA Manager on a regular basis pending RA activities
- Ensure compliance with corporate SOPs referring to regulatory activities and the company’s guidelines.
- Keep up-to-date of new legislation and changes in regulation in order to assess their impact on the registration policy, make the necessary changes and provide high level support to internal and external stakeholders.
- Update the electronic databases accurately and on a timely manner, in accordance to corporate guidelines and standard requirements
- Provide translation of documentation related to the submission when required
- Ensure an efficient coordination between different internal & external stakeholders.
- Ensure archival of regulatory documentation
- Ensure execution of Egypt product release:
- Coordinate with the customer service, the distributor and the authorities on the shipment.
- Interact with the Distributor and the HA to follow up on analysis and ensure final release of the product.
- Coordinate and follow up with the distributor and national labs, on the availability of reference standards, samples and other analysis requirements.
- Provide a weekly feedback on the shipment and release product status.
- Field work 70% - 30% office work
Academic Background & Professional Experience
- University Degree ideally in Pharmaceutics or in Chemistry or Biology or in another related field
- Minimum 2 to 3 years of experience with Regulatory Affairs background
Required Knowledge / Skills / Languages:
- Regulatory, Pharmacovigilance and market knowledge
- Very good knowledge of the relevant terminology
- Identify the key priorities to be achieved on a monthly/quarterly basis through effective planning and time management.
- Proactively identify and address bottlenecks and ‘overload’ problems.
- Consistently revisit plans to ensure fitness for purpose.
· Encourage working with cross-functional teams to expertise and best practice.
- Excellent PC Skills
- Excellent command of English and Arabic language
- French Language is preferable
Key Competencies:
- Instills Trust – Gaining the confidence and trust of others through honesty ,integrity & authenticity.
- Plans & Aligns – Planning and prioritizing work to meet commitments aligned with organizational goals
- Communicates effectively: Developing and delivering multi-mode communications that convey a clear understanding of the unique needs of different audiences.
- Drive Results :Consistently achieving results ,even under tough circumstances
- Collaborates: Building partnerships and working collaboratively with others to meet shared objectives
- Courage: Stepping up to address difficult issues, saying what needs to be said
How to apply:
If you are interested to join our team, please send your Resume (in English Language) to
hr_egypt@leo-pharma.com mentioning in the subject: "Regulatory Affairs Officer".
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