junior regulatory affairs manager (50%) in Zürich

Our client, a research based pharmaceutical company leader worldwide, we're actively looking for a : 

 Junior Regulatory Affairs Manager (50%)

Location: Zurich

Contract Length: until Dec 2018

Startdate : to be discussed 

Position purpose:

• Processing of new licenses, maintenance and care of licenses and maintenance of the marketability of drugs and medicinal products in Switzerland and any other associated /relevant activities.

Primary Responsibility:

• Determine the appropriate licensing strategy in accordance with HRA and/or RAM
• Coordinate collaboration with WSR
• Obtain and assess the marketing authorization documentation, compile and customize it to meet the local requirements of Swissmedic
• Ensure the update of all relevant databases
• Ensure that the applications are submitted as quickly as possible with the best possible labeling
• Ensure that new marketing authorisations (MAs), line extensions (LEs) are processed in accordance with local laws and guidelines as well as local SOPs
• Carry out file processing on schedule, if necessary speed up the process by making formal / informal contacts with Swissmedic
• Participate in discussions / negotiations with the authority and provide appropriate organization of meetings with the authority
• Maintenance of marketing authorisations (e.g. core data sheet updates, variations, renewals, PSURs, MR-conditions
• Create and maintain the Local Product Document (LPD), Local Language document (LLD; Fachinformation), the local Patient Information Leaflet (PIL; Patienteninformation) and the abbreviated LLD (FI-kurz; Fachinformation kurz) as well as the packaging elements as appropriate in accordance with the local procedures and Swissmedic guidelines
• Representation of the company / division with internal and external customers
• Collaborate with HUB colleagues to ensure HUB support is appropriately aligned with Swissmedic requirements
• Make sure that local laws and guidelines as well as local SOPs are always met
• Provide support for all audits under Medical Director / Platform Head (Regulatory/Safety) Accountability, including audit corrective and preventive action plans (CAPAs).

Technical Skills Requirements:

• Extensive knowledge of the current Swiss regulatory and drug laws environment, knowledge about other legal environments (EU, US, etc.) is of advantage
• Very good knowledge of German and English, good knowledge of French, knowledge of Italian is of advantage
• Solid knowledge of pharmaceutical analytics technology, pharmacology, toxicology and medicine

Qualifications:

• Academic degree in natural sciences (pharmacy, chemistry, biochemistry, biology or medicine)
• Min. 2 years work experiences in Regulatory Affairs
• Knowledge of or experience in project management techniques is of advantage
• Clear verbal and written communication
• Strong skills in productivity, organizational and time management in order to meet strict regulatory compliance goals
• High quality standards
• Ability to work independently as well as part of a team

We are looking forward to receiving within your application:

• your CV in English
• latest Work Certificates
• your Motivation Letter  
• ID/passport copy
• Copy of Work Permit

Apply now to be considered!

For more information and your application, please contact: Filipa Lessa, Recruiter Lifesciences, Randstad Professionals, filipa.lessa@randstad.ch, +41 58 201 55 50