Senior Regulatory Affairs CMC en Michael Page

Excellent opportunity to work as a Senior Regulatory Affairs CMC in a API Multinational Company within an international environment.

Detalles del 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 del candidato

• 
  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
  

Oferta de empleo

• Valles Occidental (Barcelona) based