full time permanent employment in a young working environment and positive culture.
The Regulatory Affairs Specialist Project Manager will provide regulatory support to ensure regulatory compliance and obtain national and international authorizations and their lifecycle maintenance under the direct control of a supervisor.
Essential tasks and responsibilities:
Support the preparation, submission, and maintenance of world-wide product registrations in the main global markets:
- NATIONAL (Switzerland, Germany, Austria, UK, and Ireland)
- INTERNATIONAL MARKETS, such as:
- NORTH AMERICA (Canada, US, Mexico)
- LATAM (Central and South America)
- MENA REGION (Middle East and Africa)
- ASIA PACIFIC
- EUROPE (Western and Eastern Europe)
- Critically and autonomously prepare/revise the regulatory documentation for registration purposes (MAA, variations, renewals, etc.) intercommunicating with internal departments, local partners/MAHs, and external consultants.
- Constantly remain updated on new regulations issued by HAs and other regulatory organizations.
- Review product labeling for compliance with global labeling regulations.
- Ensure the registration documents are prepared and kept updated according to the regulatory requests of each relevant Health Authority.
- Collaborate with the Quality Assurance and Pharmaceutical Development department to assess the regulatory impact of Change Controls according to the internal SOP.
- Ensure that the national texts of Company products are regularly updated and uploaded to national databases, where necessary, either directly or through local partners or consultants.
Knowledge and Skills:
- 5-year degree in a scientific discipline (Pharmaceutical Science, Chemistry, Biology)
- At least 10 years’ regulatory affairs experience
- Deep knowledge of pharmaceutical legislation and regulations
- Experience in EU registration procedures (MRP/DCP MAA, post approval changes, extensions, and renewals).
- Preferably previous experience with global registrations
- Preferably CMC (quality part of the dossier) knowledge
- Ability to resolve conflicts and develop a course of action leading to beneficial outcomes
- Ability to understand and communicate regulatory information
- Strong communication skills, both oral and written
- Very good English communication and writing skills (knowledge of French or German would be an asset)
Interested candidates should send their CV by email to Cristina Robotti at firstname.lastname@example.org or by post to the address below.
For further information please call the following number: +41 91 911 30 00.
We thank all applicants for their interest, but only candidates selected for an interview will be contacted.
MAXIMUM DISCRETION AND PROFESSIONALISM FULLY GUARANTEED.
La candidatura al presente annuncio presuppone l’accordo con la nostra informativa inerente la protezione dei dati: https://www.luisoni.ch/protezione_dei_dati