Senior Regulatory Affairs CMC – Active Pharmaceutical Ingred…

  • Profesionales y Técnicos
  • Full time
  • 2 meses -
  • Barcelona

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Descripción del trabajo

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Senior Regulatory Affairs CMC

Active Pharmaceutical Ingredients (APIs)

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
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
Cristian Atik
Indicar número de referencia para la oferta: 324481

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