Regulatory Affairs Officer (EU/UK/US)

ppProthya is dedicated to ensuring the registration (market authorization) of its medicinal products is obtained and maintained in compliance with regulatory standards. The purpose of your job as Regulatory Affairs Officer is to compile and maintain registration dossiers (EU/UK/US) to ensure that Prothya medicinal products achieve and retain market authorization. /ph3Key responsibilities: /h3ulliCompiling and maintaining registration files. /liliPerform regulatory submissions to competent authorities (EU/UK/US) required to obtain and maintain marketing authorization for Prothya medicinal products. /liliParticipate as RA lead in company-initiated projects, collecting and compiling information according to regulatory guidelines. /liliCommunicate directly with regulatory authorities regarding registration submissions. /liliInterpret and implement legislation and regulations for registration dossiers. /liliAssess registration dossiers against (inter)national legislation and authorize change controls. /liliInitiate the development of and check SPC, package leaflet, box, and label texts in accordance with legislation. /liliAssess compliance of marketing materials with the regulatory dossier and national guidelines. /liliAdvise and support other departments on national and international laws and regulations. /liliMaintain overviews of submission status of Prothya products. /liliProvide support to Manager RA and Director RA in optimizing processes and systems within the RA department. /li /ulh3Qualifications /h3ulliAcademic master’s degree in pharmacy or related study such as biochemistry, medical biochemistry, or medicine. /li /ulh3Preferred Skills /h3ulliUnderstanding of existing regulatory GxP requirements. /liliExperience in writing GxP documentation such as deviations and change control records. /li /ulh3Required Skills: /h3ulli2 years of experience as Regulatory Affairs Officer EU/UK/US or equivalent. /liliKnowledge of relevant (inter)national pharmaceutical legislation and regulations, procedures, products, and (aseptic) production processes. /liliAbility to connect diverse topics to present a complete story to the competent authorities. /liliAbility to analyze and assess diverse topics and internal documents in relation to applicable registration legislation. /liliAbility to work independently and with attention to detail. /liliAbility to plan, organize, communicate effectively, and coordinate input from multi-disciplinary teams. /liliAbility to identify bottlenecks and suggest improvements or solutions. /liliAbility to negotiate with various stakeholders on timelines and content of submissions. /liliAbility to build relationships with various stakeholders. /liliFluent written and verbal communication skills in English. /liliAct with integrity when dealing with confidential information. /liliAbility to handle psychological strain due to peak workload. /li /ulh3What we offer: /h3ulliEmployment for 36h or 40h with flexible working hours in consultation. /liliA salary between€ 4.702,26 and € 6.759,41 gross per month (based on full-time employment) /liliA budget of 16,66% (holiday allowance and 13th month) on top of your gross salary, yours to spend or to save monthly /lili30 holiday days (based on fte) /liliA personal training budget of €2,100 every three years to foster professional growth and development. /liliContribution to travel expenses from the first kilometer. /liliExcellent accessibility by public transport and private parking available. /liliA pension plan with Zorg Welzijn, providing security for your future. /liliA dynamic, safe, and challenging working environment with ample opportunities to grow, innovate, and learn, all while making a meaningful impact on the health of millions. /li /ul /p #J-18808-Ljbffr