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.
· Higher education
· 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
· Medical insurance for the employee and his children (100% coverage);
· Medical insurance for a spouse (50% coverage);
· Life insurance (accidents)
· Food allowances
· Various training programs
· Employee assistance programs
· Compensation costs for fitness (for employees who have been with the company for over 1 year)
Russia > Moscow : Metropolis Building 1
SIGNIFICANT WORK ACTIVITIES:
Awkward/forceful/repetitive (arms above shoulder, bent wrists)