Regulatory Affairs Manager
vor 2 Monaten
Proclinical are recruiting for a Regulatory Affairs Manager - EMEA to join a pharmaceutical organisation. This role is on a permanent basis and is located within the EMEA with the ability to either work remotely or on a hybrid basis.
Please ensure that you are eligible for working in the location without any sponsorship or relocation assistance.
Responsibilities:
Accountable for new proposals of marketing authorisations, and post-approval regulatory upkeep such as renewals, CMC variations, safety information updates, PSUR/RMP reporting, review of change control requests, etc.Responsible for all regulatory affair actions for launched portfolios/products within designated countries or region(s).You will arrange and assist the corporate regulatory affair team within the international growth of the recognised markets with actions which involves offering leadership and knowledge.Form a reliable registration plan and be accountable for adaptation of documents and compilation of the regulatory report to comply with local authority needs.Serve as the main point of contact for all shareholders, engage with local regulatory agencies/external partners as regulatory representative for the allocated region.Responsible for setting up a local SOP system for product registration procedure and market access linked assessments to serve a long-term foundation for business operations.The ideal candidate will prepare, arrange and evaluate the authoring, binding, and proposal of registration application materials, specifically M1 to guarantee the smooth progression of review and approval procedures in a timely manner.Key Skills and Requirements:
Educated to degree level in a scientific, life science, pharmacy or similar discipline.Familiarity with therapeutic areas, for example: oncology, cardiovascular, metabolism and the central nervous system would be ideal.Demonstrable experience within regulatory affairs in pharmaceutical organisations, with expertise in local PV and quality which would be beneficial.Expertise on FDA, EMA, and ICH guidelines with comprehension within regional legislation, policies, processes and respective regulations.Acquaintance with registration procedures, such as formation / evaluation / proposal of MA applications, variations/supplements of post-approval management, etc.An organised individual with the capability to drive the regulatory procedure with a sense of urgency.Communication skills both verbally and in writing.Works well with others both internally and externally, such as CMO, CRO, etc.Fluency in both Arabic and English would be ideal.Prior involvement working within a multinational pharma from Asia would be advantageous.If you are having difficulty in applying or if you have any questions, please contact Evelyn Li at e.li@proclinical.com.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
#Regulatory
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