Junior Regulatory Affairs Manager (50%) in Zürich

veröffentlicht
Kontakt
Barbara Sorce, Basel Professionals Health Care & Life Sciences
Jobtyp
Contract
jetzt bewerben

job details

veröffentlicht
Ort
Zürich
Sektor
Life Sciences
Jobtyp
Contract
Referenznummer
10793
Kontakt
Barbara Sorce, Basel Professionals Health Care & Life Sciences
Telefon
058 201 55 50
jetzt bewerben

Stellenbeschreibung

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: Catherine Schubert, Recruiter Lifesciences, Randstad Professionals, catherine.schubert@randstad.ch, +41 58 201 55 54