Regulatory Affairs Specialist NDM

Acino Pharma

This position is based in Cairo, Egypt and will report directly to the Regulatory Affairs Manager, META. The role will be responsible to support on all the assigned Regulatory activities within the Non-Direct Markets (NDM) region (Sudan, Libya, Yemen, Morocco, Jordan and Lebanon). The role will also ensure all Regulatory activities are conducted in compliance with local regulations and company policies and SOPs. Manage Business Partners within the NDM region.

Your Responsibilities will be:

• Support the Regulatory Affairs Manager on all the assigned Regulatory activities within the NDM.
• Keep up-to-date and archive all relevant regulations and Regulatory guidelines (Regulatory Intelligence); inform Global RA on any changes/updates to the local requirements.
• Manage the preparation, submission, and follow-up of all regulatory applications in the assigned region (variations, product renewals, site registration renewals, new registrations etc.).
• Initiate the preparation and translation of proofread printed artwork ensuring compliance with the registered Product Information.
• Responsible of ordering and legalization of local CPP and other module 1 documents for local products.
• Perform regulatory due diligence on module 1 for all assigned products for NDM according to internal process/guidance according to EU/local Region regulatory requirements.
• Ensure that the regulatory file is complete and available for dispatch to the distributor and timely submitted to the local Health Authorities.
• Work closely with Global RA on the submission strategy and the completion of the regulatory dossiers in line with local regulations.
• Co-ordinate the responses to requests by the authorities during the evaluation process and check the correct handling of deficiency letters within a specific timeframe.
• Create and maintain a full up-to-date database and archiving system for tracking the regulatory activities in the assigned region.
• Adhere to Acino internal policies and standard operating procedures designed to ensure patient safety, including mandatory attendance at pharmacovigilance training.
• Forward all received Product Quality Complaints, Adverse Events and Medical Information Requests to the relevant person in Quality Assurance/ Pharmacovigilance/ Medical Affairs.
• All trainings to be completed as per training plan.

Your Profile:

• Education in Pharmacy, natural Sciences or relevant discipline.
• Minimum of 3 years experience working in the Pharmaceutical industry in Regulatory Affairs and extensive experience in preparation and submission of Regulatory files to local Competent Authorities in the region.
• Proven ability to effectively work collaboratively in cross functional teams.
• Ability to work in a highly dynamic business environment.
• Cross-cultural awareness and ability to work across geographical markets.
• Multi-task ability and work well under pressure and tight deadlines.