Job description
Position Overview - Basic Functions & Responsibility
· For assigned products, ensures timely preparation, submission and appropriate follow-up of new Marketing Authorization applications to the local authorities.
· Ensures maintenance of assigned, authorized products through timely submission of variations, renewal applications, and supplemental marketing authorizations.
· For assigned products ensures timely, accurate and compliant labeling translations and artwork preparation.
· For assigned products and tasks, stays updated on late MSD pipeline filings, relevant regional and local regulations and guidelines and to develop and maintain positive relationship with key players in the regulatory environment. Designs and implements regulatory ad-hoc local action plans, as necessary.
· Collects relevant public available regulatory information (regulatory intelligence) and keeps relevant persons appropriately informed.
· For assigned products and tasks, works alongside the BD, locally, regionally and globally, to support business initiatives in sub region.
· Maintains a positive relationship with internal and external regulatory contacts. GRA/RAI on sub-regional, regional and global level, MMD, EEMEA PV and WPS are the main contact points within the company. External contacts are regulatory authorities, as well as other key players in the regulatory environment.
· By discretion of Regulatory Affairs Management and due to organization and work load, all listed activities need not to be performed.
· Applicable to incumbent with direct reports only: Responsible for people management of applicable Regulatory personnel in Egypt and provides clear leadership for these. Secures appropriate career development for the applicable staff and is responsible for keeping the applicable staff scientifically and legally updated within the Regulatory area.
· Acts as substitute for Country Lead Regulatory Affairs as appropriate.
Skills Required:
Must be hold a MS degree in pharmacy or other life science. A minimum of 2 years experience in a Registration Department or equivalent, which should include dealing directly with regulatory Agencies. The incumbent must be familiar with local and regional legislation procedures and guidelines governing pharmaceutical products.
Ability to communicate well verbally and in writing is essential, as are good organizational and planning skills. The incumbent should possess a meticulous attention to detail, and be flexible enough to successfully handle conflicting time pressures and a large volume of work. A mature and disciplined approach to work is essential as is the ability to coordinate the work of others. The incumbent should be able to demonstrate diplomacy and assertive skills in dealing with internal and external parties. The incumbent must demonstrate proficiency in local and English language as well as PC use with regard to word-processing, spreadsheets, database application, and internet.
For seniority, a minimum of 4 years experience in a Registration Department, dealing with most aspects of registration and experience in supervising others. A sound appreciation of the interactions and relationships of the dept with other groups internally is expected. Must have client oriented approach and work according to the MSD leadership vision.
