Specialist Global Regulatory Affairs API

Hely: Budapest
Cég: XELLIA Gyógyszervegyészeti Kft.
Kategória: Egészségügy, Gyógyszeripar

Lifecycle management of approved regulatory filesDocumentation support in registration and renewal proceduresPreparation of ASMF/DMF/CEP according to project timelines, ensuring compliance with regulatory requirements and facilitating submissions to the AuthoritiesPreparation of annual reports/annual amendments and variation packages for relevant DMFsPreparation of Quality Overall Summaries under supervision of more expirienced colleaguesHandling deficiency letters received from Regulatory Agencies, ensuring proper implementation of any changes in manufacturing or control processes with support of more expiriieced collegues if neededHandling the queries received from Customers from regulatory and technical perspective with support of more expiriieced collegues if neededPrepare, retrieve, review for accuracy, completeness and compliance with regulations, approve and collect all supporting documentation for regulatory submissions, i.e. manufacturing process, specifications, analytical procedures and validation reports, batch records, etc.Coordination the collection and organization of technical documentation to ensure that products meet the required regulations and client demandsContribute to the product development and maintenance of the existing portfolio from regulatory aspectsDeap participation in manufacturing site technical transfers (internal and external) with regulatory expertise with support of more expiriieced collegues if neededEvaluate change controls, communicating any relevant changes in products or facilities to clients and Authorities, ensuring transparency and compliance with support from more expirienced colleaguesSOP/WI preparationContinuous monitoring of guidelines, FDA, EMA, EDQM, ANVISA and MHRA home page and ensure their timely implementationWork in EDMS/TrackWiseContinuous development in the area of regulatory affairsProviding all needed regulatory support, including opinion or advice to all other stakeholdersParticipating in multifunctional team meetings Minimum a bachelor's degree in Pharmacy, Chemistry, Biotechnology or related studies (master’s degree is an advantage)More than 3 years of experience in API regulatory affairsExcellent English communication skills (spoken and written)Knowledge and deep understanding of GMP and hands-on experience in applying it to an operational environmentCapatibility to evaluate change controls from thier areas independently (use of Trackwise system for handling change controls is advantage)Thorough proficiency in MS OfficeMust work well under deadlines and have excellent attention to detailMust be selfdisciplined to plan, schedule and arrange own activities in alignment with projectsDemonstrated ability to handle multiple tasks in a fast-paced environmentProactive working approach and developed stakeholder management skillsExcellent interpersonal and communication abilities Competitive compensation and benefit package„Nordic-style” culture – dynamic teamwork, good working atmosphere, flexibility, maintaining work-life balanceOpportunity to learn and developGood team spirit and friendly colleaguesStable international company backgroundMultinational working environmentHome office opportunity

Címkék: Employee status, College

profession.hu - 4 napja

További információ és jelentkezés