pharmalex_job_career

We are growing, grow with us

Want to work in a dynamic company with daily new challenges and opportunities?  Then is PharmaLex your career opportunity.
 
PharmaLex is one of the leading service companies for the global pharmaceutical industry and specializes in all aspects of drugs and medical devices approval of the development to market and any action to product maintenance make it as effective as possible.
The success of our company grows with the excellent expertise and the high motivation of our employees.
 
If for you, your profession is not only a job but a mission too and you enjoy working with people, then you are welcomed to come and join us.
 
To strengthen our successful team, we are looking, as earliest as possible for a:

Manager Regulatory Affairs Applications/Submissions

Your Job

  • Assesses regulatory intelligence to assist in the development of local, regional, and global regulatory strategies
  • Evaluates the regulatory environment and contributes to providing internal advice throughout the product lifecycle to ensure product compliance
  • Assists in the development of regulatory strategy and updates strategy based upon regulatory changes
  • Evaluates proposed products for regulatory classification and jurisdiction
  • Determines requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities
  • Negotiates with regulatory authorities throughout the product lifecycle
  • Provides regulatory input and technical guidance on global regulatory requirements to product development teams

We offer you

  • Diversified and challenging job
  • Open and collaborative organisational culture with emphasis on knowledge-sharing
  • Flexible working hours
  • Continuous development opportunities through knowledge and experience as well as training
  • Location: Madrid or Zaragoza

Your Profile

  • Degree in natural sciences (preferably pharmacy, chemistry or biology). A Master degree in Regulatory Affairs is a plus 
  • At least 3-5 year of professional experience
  • Project management, writing, coordination, and execution of regulatory items
  • Perform technical and scientific regulatory activities
  • Usually works with minimum supervision, conferring with superior on unusual matters
  • Professional written and spoken communication skills as well as confident English (C1 Advanced)