Main responsibilities : Main responsibilities
Responsibility for developing a comprehensive registration strategy in close cooperation with the personnel dealing with sales, operations, vaccines and marketing, taking into consideration Company's interests and normative requirements.
Responsibility for insuring earliest possible registration of all new or in-line products, claims, formulations and / or strengths, along with price registration / re-
registration, shelf-life changes according to adopted registration strategies (and company's high ethical standards policy).
Reviewing registration files and all related documentation of the Company's products and preparing such documentation in line with local normative regulations.
Preparing Application Forms and other documentation for filing and registration of new products. Ensuring that all documentation, samples, commercial packs and other items are provided to relevant agencies as needed.
Establishing and maintaining good working relationships with all involved regulatory and other institutions. Keeping track of new normatine documents related to registration of medicines.
Cultivating best possible relations with local regulatory bodies and opinion leaders and enhancing the Company's image in the medical community in general.
Handling all issues related to changes in the Company's products status and performing regulatory related surveys in the country.
Preparing and reviewing package labels and inserts for Company's respective new and in-line products registered in the country.Requirements :
At least 2 years of experience in Regulatory Affairs (medical equipment, pharmaceuticals, chemical products)
Strong willing to develop in IVD regulatory affairs field;
English written, spoken
Excelent knowledge of MS Office (Word, Excel)
Personality : team player, well organized, attentive to details, enthusiastic, quick learner
Ability to work with big amount of information