\\n I\\xe2\\x80\\x99m currently seeking a Regulatory Affairs professional to join my clients team as a Regulatory & Quality Assurance Expert to get trained, and act as the deputy Responsible Person (FvP) and Deputy Local Safety Officer (DLSO).

This position will see you execute the regulatory submissions for their existing portfolio and also new product acquisitions for Switzerland, while also supporting pharmacovigilance and Medical processes, maintaining the QMS.

The ideal candidate would be someone who is deadline driven, has a strong sense of urgency and commitment, who is also innovative and pro-active.

Overall responsibility:

Execute CH regulatory submissions for existing portfolio and new product acquisitions. Supporting function for maintaining the Quality Management System. Supports Pharmacovigilance & Medical processes. Liaises with HQ Regulatory Affairs Team and with other internal and external stakeholders. Interface between the departments of R&D, Market Access, Logistics and Marketing & Sales. Act as full Deputy of the Responsible Person (Fachtechnisch verantwortliche Person; FvP) and Deputy as Local Safety Officer (DLSO)

Main responsibilities:

• Preparation, submission and tracing of Market Authorisation(MA) dossiers (all kind of variations, labelling \\xe2\\x80\\x93 and, safety updates)., evaluation of variations, communication with authority
• Supports to maintain and improve a local quality assurance system in accordance with Swiss legislation and good distribution practice (GDP), assists in the development, writing and implementation of SOPs
• Deputy Responsible Person (Stellvertretung Fachtechnisch verantwortliche Person, FvP)
• Supports pharmacovigilance obligations, takes responsibility as Deputy Local Safety Officer (DLSO) (Stellvertretung Pharmakovigilanzverantwortlicher)

Key Requirements / Knowledge:

• Master degree in medical, pharmaceutical or science discipline or equivalent.
• Record of experience in pharmaceutical industry for at least 1 \\xe2\\x80\\x93 2 years
• Demonstrated understanding of regulatory and compliance guidelines (GDP, GVP)
• Native speaker German, business fluent in English
• MS Office requirements

If you or a friend are looking for a new and refreshing role or have any questions about the position, then give me a call, drop me a message, or apply directly below and get ahead of the crowd! I look forward to hearing from you.

For a confidential discussion about this role, or to apply, then send your CV to c.buckley@nonstop-recruitment.com or call me, Corey Buckley, Recruitment Consultant \\xe2\\x80\\x93 Life Sciences \\xe2\\x80\\x93 Switzerland, at +41 435 080 817 (intern 3117). Please feel free to visit my LinkedIn profile to see my references/recommendations.

NonStop is one of the largest and fastest-growing specialised life sciences recruitment companies in Europe. We are proud members of the APSCo life sciences group who ensure we meet the highest quality standards within the recruitment industry. Our offices are located in the UK, Luxembourg, Switzerland, Romania, the US and the Czech Republic and we hold labour leasing licences across Europe.\\n \\n \\n \\n \\n \\n

\\n\\n NonStop Consulting\\n \\n\\n

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