pharmalex_job_career


We are growing, grow with us

If you like to work in a dynamic company, facing new challenges and opportunities every day, then PharmaLex gives you the chance to launch and develop your career.

PharmaLex combines local expertise with global reach in the area of Development Consulting, Regulatory Affairs, Pharmacovigilance, Epidemiology & Risk Management and Quality Management & Compliance. We have extensive experience in all major therapeutic areas and product groups including advanced therapy medicinal products, biopharmaceuticals, medicinal & borderline products as well as alternative therapeutic approaches.

PharmaLex has a presence in more than 17 countries with a team of 750+ professionals. We are specialized in effectively designing all aspects of drug and medicinal product registrations – ranging from early development and market entry to product maintenance.
A team of unique people with different skills and strengths stands at the heart of our success. Become part of this diverse team and benefit from flat hierarchies in a collegial working atmosphere.

We are looking for motivated, committed candidates who will enjoy working independently within our successful team in a challenging environment and continually develop our company. So, if your career is not only your job, but also your passion, and you enjoy working and communicating with people, come and join us! 

To strengthen our successful team in France, we are looking, as earliest as possible for a:

Regulatory Specialist (f/m/d)

Your Job

  • Prepare and contribute to the writing/review/preparation of regulatory dossiers and documents for medicinal and/or biotech products
  • European dossier submissions in eCTD format (CP, MRP/DCP, renewals)
  • PSUR/PSUSA submission
  • Parallel import activities
  • Packaging and labelling activities
  • Regulatory database updates
  • Ensure compliance with the quality procedures

We offer you

  • Diversified and challenging job
  • Cooperating partnership and leeway
  • Flexible working hours
  • Continuous development opportunities through knowledge and experience as well as training
  • We foster commitment – while giving room for flexibility
  • We promote and demand – while allowing a work-life-balance
  • We motivate people – we think ahead
  • We bring people together – while focusing on connectedness

Your Profile

  • Completed University degree in Pharmacy with a Master degree in Regulatory Affairs is a plus 
  • 1 to 3 years of professional experience and, technical/project management experience
  • Familiar with French and European regulatory requirements for medicinal products
  • Distinctly strong service orientation
  • Content-related experience in at least one relevant area of Regulatory Affairs
  • Native French speaker and fluency in spoken and written English
  • Ability to manage several projects with limited guidance
  • Independent approach to work, flexibility and dedication
  • Strong communication skills, social competency, integration capacity
  • Strong sense of responsibility, organizational skills and intrinsic motivation