RA Life Cycle Management CMC Specialist
Hays
One of our clients from the pharmaceutical industry is building a new hub in Warsaw and is looking for talented professionals that would contribute to its success by joining the new team.We are looking for several Senior Regulatory Affairs Specialists who would be responsible for ensuring compliance with regulatory requirements during the lifecycle management of the company’s marketing authorisations. The role involves developing and executing regulatory affairs strategies, preparation of regulatory variation packages as well as authoring the CMC part of the regulatory dossiers.The position requires a deep understanding of the pharmaceutical manufacturing processes, analytical testing and pharmaceutical legislation and guidelines, coupled with strong communication skills.The position will collaborate closely with colleagues across functions, such as chemists, formulation specialists and co-workers within Quality, Supply Chain, Manufacturing and Sales to ensure variations are managed in due time to ensure uninterrupted supply of our medicines to patients.Office location: WarsawHybrid model: 3 days office-based, 2 days home-officeMain responsibilities:Regulatory Strategy and Compliance:
Document Preparation and Submission:
Liaison with Regulatory Authorities:
Daily Operation Tasks:
Requirements:Education:
Experience:
Regulatory Knowledge:
Communication & Collaboration Skills:
Attention to Detail:
What you’ll get in return
Hays Poland sp. z o.o. jest agencją zatrudnienia zarejestrowaną w rejestrze prowadzonym przez Marszałka Województwa Mazowieckiego pod numerem 361.
Warszawa, mazowieckie
Fri, 02 May 2025 22:18:33 GMT
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