• Publicar trabajo
  • Subir CV
  • Acceder
Ver oferta completa

REGULATORY AFFAIRS MANAGER [INTERIM MATERNITY]

Descripción de la oferta de empleo

Oxford Global Resources is seeking a Regulatory Affairs Manager for a 6-month interim project to support a leading company headquartered in Barcelona through our consulting services division.Key Responsibilities:Oversee and manage the regulatory processes for international marketing authorizations (MAs) of pharmaceutical products, including those of the client and its subsidiaries. This includes ensuring the maintenance of existing authorizations and obtaining new ones as needed.Manage the lifecycle of pharmaceutical product MAs by preparing and organizing applications, dossiers for new authorizations, and submitting variations or extensions.Provide guidance on regulatory strategies for new international registrations, certifications, and MAs.Liaise with regulatory authorities, partners, and external service providers to ensure smooth approval processes.Coordinate internal communication related to planned approval activities and post-approval processes, in line with applicable drug laws, EU regulations, and GMP guidelines.Assist in evaluating external MA documents for in-licensing decisions through due diligence.Serve as the primary point of contact for Health Authorities, stakeholders, and regulatory inquiries.Prepare, review, and revise expert reports related to product approvals.Draft, update, and adapt product information documents (e.g., patient instructions, professional information, packaging labels) for pharmaceutical products.Utilize Data Management Systems (e.g., RIMS) for regulatory processes.Requirements, Skills, and Qualifications:Bachelor’s degree in Life Sciences or a related field.Fluency in English for business communication.Minimum of 5 years of experience in International Regulatory Affairs within the pharmaceutical industry, ideally at a global level.In-depth knowledge of international registration processes and pharmaceutical legislation across key global markets.Proven ability to collaborate effectively with partners and regulatory agencies, securing approvals and managing product lifecycle across various regions.Knowledge or experience with Orphan drugs is a plus.Familiarity with Data Management Systems (e.g., RIMS).Strong attention to detail, with an ability to manage multiple priorities.Excellent critical thinking, initiative, and interpersonal communication skills, with a proven ability to influence.
Ver oferta completa

Detalles de la oferta

Empresa
  • Oxford Global Resources
Localidad
  • En toda España
Dirección
  • Sin especificar - Sin especificar
Fecha de publicación
  • 24/10/2024
Fecha de expiración
  • 22/01/2025
Cómo detectar ofertas falsas
Customer Success Manager
Recruit4work SL

Requisitos del puesto completion of a master’s degree/mba or an equivalent qualification is required, coupled with practical work experience, preferably in hr tech, within roles such as customer success manager, account manager, or delivery manager... demonstrating strong communication and presentation......

ECOSYSTEM RELATIONS MANAGER
Fundación Valenciaport

• content management and creation for opentop social networks, opentop web site, press releases, etc, acting as community and communications manager of opentop... • manage the relationships with the different stakeholders of the innovation ecosystem, with focus on startups, entrepreneurs, vcs and accelerators......

Community manager madrid
Tarotalia sl

Descripción:empresa española de terapias alternativas y astrologia precisa incorporar una community manager para su proyecto en madrid... se busca persona adaptable, constante y dinámica con posibilidad de continuidad en la empresa e incentivos por objetivos preferiblemente freelance (no obligatorio)......

Marketing y Ventas · Growth Manager
Smart&Fun

Especialista en marketing y ventas, con experiencia demostrable para integrarse de forma inmediata en el gran equipo de nuestra empresa tecnológica, gestionando toda la estrategia de marketing de nuestros dos principales proyectos digitales tecnológicos innovadores, consistente en un saas buscamos growth......

Sales Account Associate or Manager (ingles+español)
inte-QT

Join our growing team as a key account manager in the gbs team, you will focus on growing and developing existing clients, as well as generating new business by identifying, implementing and executing new strategies... possess excellent communication skills (both verbally and written) and employ these......

VIP Account Manager - Cyprus
Triskel Consulting

Stay up-to-date with the latest product developments, game features, and promotions to effectively communicate this information to vip players... a customer-centric mindset with a firm commitment to delivering top-tier customer service... profound understanding of the your country igaming market, along......

Store Manager
Anonimo

Requisitos del puestocurrently, we are on the lookout for a visionary store manager who embodies the essence of our brand – someone who can seamlessly blend the art of salesmanship with the science of team motivation... step into a world where passion meets precision, and where every sale is a testament......

Supply Chain Manager
Involve rh

Confidencial cuenta con una posición como supply chain manager para optimizar la cadena de suministro para garantizar la eficiencia en la distribución de productos y la satisfacción del cliente... analizar y optimizar los procesos de logística y distribución... 000,00 € eur por año bruto jornada laboral:......

LEGAL MANAGER - CHAMARTÍN (MADRID) - 1243460
Temporing

Ciudad: madrid desde temporing buscamos perfiles para cubrir la posición de manager legal en una importante empresa de gestión inmobiliaria ubicada en la zona de chamartín en madrid... banda salarial de entre 25... tramitación completa de procesos precarios, derechos reales o delitos de usurpación......

Community Manager Medio Tiempo
Involve rh

Involve rh cuenta con una posición como community manager para crear y mantener una comunidad online activa y comprometida, gestionando la presencia de la marca en redes sociales y generando interacción con los seguidores... 000,00 € eur por mes bruto jornada laboral: de lunes a viernes modalidad: presencial......