International Regulatory Affairs Manager CMC

• International Regulatory Affairs Manager CMC |Active Pharmaceutical Ingredients (APIs)

API Multinational Company

• 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
  

• Valles Occidental (Barcelona) based

• 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