lilian louis louis

Senior Regulatory affairs responsibleFull Time

• Job Details:My Job Responsibilities as a Regulatory Affairs Responsible at Paxal Pharmaceutical company match the qualifications you are seeking as the Regulatory Affairs Specialist . My Responsibilities included : • Handling all regulatory issues with the concerned local authority • Preparation and timely submission of registration requested documents for Human drug products and Dietary Supplements according to ministerial decrees (applying for new registration- creation naming lists- layout - pricing files -Hard file submissions –stability studies & in vitro dissolution studies submission – Bioequivalence studies submission- New box availabilities) and follow up till receiving final registration certificate in accordance with production, Marketing and sales needs. • NODCAR responsibilities: Preparation NODCAR registration files and fulfill all requirements, follow up analysis process and Securing the routinely release of already registered and marketed products duo to variation required. • Maintenance of the already existing marketed products and preparing and submission of variation files and follow up till final approval. • Follow up Re-Registration files. • Pharmacology and artwork related activities (Inserts creation and translation, Handling Safety labeling updates • Preparing and submission of Promotional material files. • Handling Inspection related complains. • Communicating globally to fulfill all required needed by EDA. • Importation of raw material related activities, Creation import permission files and annual import plan and consequently releases. • Communicating with others companies in case of Toll-In and Toll-Out • Cooperating with Toll Manufacturing Responsible to resolve issues related to Pharmaceutical Factories . • To anticipate and resolve complex regulatory issues independently and via influencing the authorities using strong access and good relations to shape the environment. I hold a valuable certificates as : - Certificate of attendance of Training& Development Module in HR diploma at AUC - "The Trainer "Certificate from Eslasca business school - Certificate of Training Basics of “ Drug Regulatory Affairs “ from RAY –CRO Training Academy . After working for a long Time in the Pharmaceutical industries I gained a great experience & I have been able to develop and acquire a strong Communication , Presentation , Negotiation skills and Eagerness to learn new Technologies and Sciences which allowed me to make a great progress in my career pathway. Some of the required skills that I have been mastered during working in my position are sense of urgency and proper planning to my duties with accurate time frame which are essential & have a great benefit in dealing with all departments of EDA & Nodcar on daily basis I would ensure everything was done the right way and pay a great attention to details & I keep up with the governing bodies to stay abreast of the latest changes of EDA