Regulatory Affairs Supervisor
6th of October, GizaPosted 3 years ago95Applicants for1 open position
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- 6In Consideration
- 0Not Selected
Job Details
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Job Description
- Job Summary:
- Interacting and communicating with regulatory organizations and authorities to expedite drug registration in addition to reviewing the preparation of registration documents and ensuring the unambiguousity of the content for all submitted documents as well as following up on changing regulations in order to maintain the license of already registered products.
- Duties & Responsibilities:
- Contributing in the development of registration strategies, analyzing regulatory procedures and executing registration plans.
- Supervise on implementation of procedures for new product registration in order to attain regulatory approval within the required timeframe.
- Supervise on preparation of regulatory documentation while coordinating with the concerned functions to ensure documents’ comprehensiveness before submission to regulatory organizations.
- Liaising with regulatory organizations to submit and approve new registration applications and maintain existing licenses.
- Preparation, Submission & Follow up any variation needed for any product till getting the needed approvals to release.
- Communicating with regulatory authorities to negotiate and discuss issues related to products registrations in order to expedite the drug registration process.
- Collecting and evaluating scientific data and providing advice on legal and scientific constraints related to drug registration.
- Following up on pharmaceutical products changing legislations in all aspects and updating the Regulatory Affairs Officer and stakeholders with such changes or any new decree related to registration.
- Specifying labeling and packaging requirements and reviewing labels, leaflets and art work content before submission and implementation.
- Supervising the preparation of HIKMA Egypt regulatory affairs database to include product list, product registration status and registration requirements.
- Ensure full compliance of the marketed products and marketing/sales activates with EDA regulatory requirements and internal polices and procedures including packaging and import procedure.
- Collaborate with the R&D, Quality, Production, supply chain, Marketing and sales team members to gather all the relevant information required for submission.
- Coordinate with central regulatory team and other concerned departments to fulfill the registration requirements of Biosimilar, imported and license products
- Gathering & collecting required information and necessary data to demonstrate the quality, safety and efficacy of products needed in the preparation of Common Technical Dossier.
- Preparation, revision, Submission & follow up of quality modules till getting approval.
Job Requirements
- Bachelor’s degree in pharmacy.
- Excellent English Command.
- Overall experience in Regulatory Affairs of 6-8 years.
- Excellent verbal and written communication skills, including ability to effectively communicate with internal & external parties.
- Excellent computer proficiency (MS Office, word, Excel, PowerPoint & Outlook).
- Must be able to work under pressure and meet deadlines.
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