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 and in teams, then you are highly welcome to  join us.
 
To strengthen our successful team, we are looking for a:
 

(Senior) Manager Regulatory Affairs (f/m/d)

Your Job

  • Planning and implementation of approval procedures in the EU (MRP, DCP, CP and purely national procedures) and in emerging markets as well as of life cycle management procedures (variations, renewals, MAH transfer etc.) worldwide
  • Communication in the project team, with customers, local partners and authorities in an international context
  • Revision of approval documents and text management (labeling management)

We offer you

  • Diversified and challenging job
  • Cooperating partnership and leeway
  • Flexible working hours based on trust
  • Continuous development opportunities through knowledge and experience as well as training

Your Profile

  • You have successfully completed a degree in pharmacy, medicine or other life sciences
  • You have at least 3 years of professional experience in marketing authorization with a focus on the EU or non-EU marketing authorization procedures and ideally have experience in launch management (DE), labeling management and clinical trial applications (CTA) as well as marketing authorization procedures in non-EU countries
  • You have sound knowledge of current pharmaceutical and regulatory requirements (EU)
  • You have experience in project management, you are multi-tasking capable, enjoy consulting customers and have an affinity for databases and project management software
  • You are a team player, communicative, conscientious, accurate and responsible
  • Flexibility and willingness to travel
  • Confident MS Excel and Word knowledge as well as business fluent English skills complete your profile