Join a Leading Global Pharmaceutical Consultancy as a Senior European Regulatory Affairs Manager!
Are you an experienced regulatory affairs expert looking for an exciting opportunity to lead and make a significant impact? Our leading global pharmaceutical consultancy, with European affiliates in the Czech Republic and the United Kingdom, is seeking a dynamic Senior European Regulatory Affairs Manager to join our team.
About the Role:
The leading Global pharmaceutical consultancy with its European affiliates in Czech Republic and also the United Kingdom is looking for a experienced regulatory affairs expert for the position of Senior European Regulatory Affairs Manager. As the Senior European Regulatory Affairs Manager, you will be at the forefront of our regulatory affairs your main responsibility will be, within the assigned registration projects, for all dossier management including dossier compilation and coordination activities for the entrusted products with line management of junior RA team members and direct cooperation with EU affiliates as well as EU Authorities.
Key Responsibilities:
Active management of registration projects during the whole life-cycle of the product (all types of processes - new registration via CP, DCP, MRP as well as national , renewal of registration, variations, withdrawal of registration, sunset clause or its equivalent, etc.)
Ensuring the registration procedures are ongoing according to the registration plan
Compilation of the registration dossier (focusing on Module I, Module II and Module IV nd Module V – manufacturing modules in cooperation with manufacturer) and its subsequent processing in CTD, eCTD, NTA, ACTD, or possibly another dossier format according to the current legislative requirements of the country
Close cooperation with the Regulatory team in European affiliate in preparation of registration processes and liaison with EU Authorities
Active participation on key company processes (change control management, risks assessment, reporting…)
Oversee maintenance and training of colleagues in operation of assigned software used for Regulatory purposes
Liaison and cooperation with internal departments and external partners
What We’re Looking For:
Degree in Pharmacy, Medicine or other Life Sciences
Advance knowledge of marketing authorization process of medicinal products and of the CTD dossier
Excellent regulatory affairs experience in compilation of dossier of medicinal product
Good knowledge of English language, any other language would be considered an advantage
Good organizational and communication skills
Flexibility and reliability, enthusiasm for learning new things
Previous experience in a similar position is an advantage, particularly with regards to dossier compilation and marketing authorization applications and maintenance
Preferred Qualifications:
5 years of experience in regulatory affairs
Advanced degree (Master’s, PhD) in a relevant field
Certification in Regulatory Affairs (RAC)
Experience with electronic regulatory submission systems
Why Join Us?
Be part of a global consultancy with a strong reputation and extensive network.
Lead and shape the future of our regulatory affairs initiatives.
Collaborate with top professionals and industry leaders.
Enjoy a dynamic and supportive work environment.
If you’re ready to take your regulatory affairs career to the next level and make a lasting impact, we want to hear from you! Apply now to join our team as a Senior European Regulatory Affairs Manager.
