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