Открыт набор на вакансию regulatory affairs в г. Москва.Position:Regulatory AffairsmanagerDivision/Department:Regulatory AffairsFunction: RegulatoryScienceExpected Areas of Competence ( i.e., skills andabilities):Creates an impactful vision for the Regulatory functionin line with Company growth priorities; this vision clearlypositions the function as a co-leader in the lifecycle managementofCompany products from development throughcommercialisation.ExpertiseDevelop in co-ordination with Divisional Management aRegistration plan outlining priorities for registration activities,including new products, product renewals, variations and sourcechanges.Manage all aspects of the registration process for Companyproducts including: requisition of dossier, translation,submission, follow-up to questions, accelerated reviewfacilitation, fee payment and record keepingReview packaging and promotional materials, which providemedical claims in their promotion, relative to corporate and localregulatory requirements.Keeps abreast of Regulatory changes, competitive activities,changes in Governmental authorities and healthcare environment andcommunicates internally to the concerned functions.Influences positively Regulatory policies and relevantlegislation.Acts as a credible, influential, and respected corporatespokesperson for interactions and negotiations with RegulatoryAgencies.Provides an adequate control of A&P materials / events,based on excellent knowledge ofcorporate SOPs, internationaland local legislation, Industry / Professional Associations EthicCodes.Strategic Thinking and CreativityForesees opportunities and pre-empts changes from aRegulatory standpoint (e.g. changes in health care policies) asco-leaders in the lifecycle management ofCompany'products.Integrates effectively the expected and unexpected changeskeeping in mind overallCompany' interest.Creates new and innovative ways of doing and perceivingthings, demonstrates flexibility, open-mindedness, and adaptabilityto a rapidly changing environment.Takes calculated risks and brings added value input to keydevelopment and business decisions.Influences and impacts others through building and defendingarguments, challenges in a provocative and respectful manner,reaches consensus of opinion, and catalyzes action to meet criticalobjectives.External Networking/RelationshipsBuilds and maintains strong relationships (both formal andinformal networks) with Health Authorities, Industry Associationsand peers, key healthcare opinion leaders, and other keyindividuals in the market.Teamwork and CommunicationBuilds and maintains good strong relationships with allfunctional areas of the organisation and is a co-leader in thelifecycle management ofCompany' products from developmentthrough commercialisation.Establishes and maintains co-operative working relationshipswith peers and co-workers and has an excellent reputation as aproactive well-respected team member who willingly sharesinformation and resources and brings value addedinput.Values diversity of perspectives and enjoys reaching the bestend result through a combination of diverse viewpoints andconstructive criticism.Integrates local/regional perspective with the globalperspective in order to achieve the best end result fortheCompanyas an organisation.Establishes processes, procedures and systems that supportthe smooth flow of project operations and communications and workswith project members to evaluate and make constructiveimprovements.Builds a superior leadership team by securing the besttalent, establishing action-oriented development plans, identifyinglearning opportunities, providing on-going