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REGULATORY AFFAIRS MANAGER

Descripción de la oferta de empleo

Title: Regulatory Affairs ManagerClient: Global Pharmaceutical CompanyLocation: Remote (Spain)Role Summary:Planet Pharma have collaborated with a Global Pharmaceutical Company who are a pioneering company in dermatology, which is dedicated to developing innovative solutions that prioritize patient well-being. Through cutting-edge research, global accessibility, and ethical practices, our client strives to advance dermatological care, foster collaborations, and continuously improve treatments to meet the evolving needs of patients worldwide!They are currently seeking an experienced Regulatory Affairs Manager based in Spain, responsible to ensure the services provided by the regional regulatory affairs department are conducted according to standard operating procedures, applicable regulations and good clinical practices and to the Sponsor’s satisfaction.Responsibilities:Manages a team of Regulatory Affairs employees. Manages performance, conducts formal performance reviews and participates in talent conversation meeting.Ensures adequate resources (i.e., headcount, experience, training) to sustain regional activities of regulatory affairs group.Manages resources selection and onboarding processes for new employees.Ensures adequate training of regulatory affairs group and oversees regulatory affairs practices to ensure alignment of practices across the team through adoption and use of all process and technology tools.Ensures the regulatory affairs’ activities are delivered on time, within budget, and incompliance to SOPs and regulations. Identifies and reports out of scope activities to project team.Develops regulatory affairs’ practices, improvement initiatives, tools, processes, and training material to support departmental activitiesProvides regulatory submissions strategic advice and may act as point of contact for Sponsors and subcontractors/project teams.Oversees resource assignments and participates in the preparation, review, submission, maintenance, and tracking of regulatory authority and IRB/IEC submissions.Requirements:At least 5 years of experience in clinical regulatory affairs in the pharmaceutical, biotechnology and/or CRO industry;Experience preparing, reviewing, and submitting Clinical Trial Applications and IRB/IEC packagesExperience with oversight of preparing and submitting part I and/or part II Clinical trial applications following EU CTRHow To Apply:If you would like to discuss this vacancy further or to discuss your career options in confidence, please e-mail Elias Adem on eadem@planet-pharma.co.ukIf this role isn’t suitable for you, please let us know if you can refer anyone – any recommendations are much appreciated! Planet Pharma offers a competitive referral scheme so you will be rewarded for your help!If this role isn’t suitable for you, please let us know if you can refer anyone – any recommendations are much appreciated! Planet Pharma offers a competitive referral scheme so you will be rewarded for your help!
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Detalles de la oferta

Empresa
  • Planet Pharma
Localidad
  • En toda España
Dirección
  • Sin especificar - Sin especificar
Fecha de publicación
  • 16/04/2024
Fecha de expiración
  • 15/07/2024
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