Oferta desactivada

Acerca de nuestro cliente API Multinational Company Descripción de la oferta Lead and coordinate regulatory activities on assigned projects and/or products world wide Develop regional regulatory strategy for new products and maintenance Collaborate...

Acerca de nuestro cliente

API Multinational Company

Descripción de la oferta

  • Lead and coordinate regulatory activities on assigned projects and/or products world wide
  • Develop regional regulatory strategy for new products and maintenance
  • Collaborate closely with team members as well as quality, technical and commercial functions on regional and cross-regional activities
  • Ensure and maintain regulatory compliance for assigned products
  • Prepare and review regulatory documents and dossiers
  • Ensure the timely provision of high quality responses to all CMC related health authority questions
  • Interact with health authorities and customer contact persons
  • Coach and develop junior team members

Perfil Buscado (H/M/D)

  • Master/PhD in Chemistry, Pharmacy or related discipline.
  • Minimum of 5 years regulatory affairs experience in pharmaceutical industry, CRO or health authority
  • Management experience
  • Expert knowledge in EU regulatory affairs CMC
  • Hands-on experience and sound understanding of the regulatory processes
  • Knowledge and experience of pharmaceutical products manufacturing and analytics
  • Significant experience on regulatory CMC related regulations and guidelines for active substances
  • Fluent in English; any additional languages are a plus
  • Highly motivated and open minded personality
  • Keen to work in an international environment and to add value to the business
  • Analytical and systematic thinker, able to work well under pressure both in teams and independently to deliver on commitments
  • Good organizational skills, business orientation and flexibility
  • Excellent communication skills

Qué ofrecemos

  • Valles Occidental (Barcelona) based

Últimas ofertas de Law Enforcement