SOPHiA GENETICS

Regulatory Affairs Assistant / temporary contract - 6 months ) Lausanne - Switzerland

Directly to Regulatory Affairs Officer with a dotted line reporting to the VP Quality and Compliance.

Product Registration

  • Work closely with and supports Regulatory Affairs Officer in daily tasks and projects.
  • Support the registration and compilation of information to ensure regulatory compliance of products for pre and post approval activities.
  • Support the insurance of compliance of SOPHiA GENETICS products with the current regulations in across the region.

Day to Day responsibilities

  • Maintain database with information on registration status of product portfolio.
  • Assist RA Officer to compile required documents from source countries for submissions, license renewals and annual registrations and maintenance of product registration dossiers for authorities.
  • Ensure that the content, organization and overall quality of all regulatory documents and samples are adequate and complies with local/regional regulatory requirements, commitments and agreements.
  • Support in the maintain database with information on regulatory requirements per country (ID card).
  • Have regular contact with RA Officer to discuss regulatory issues and updates.
  • Continuously update and advise RA Officer of any changes in regulations.

Profile of the Candidates

Education

  • Master degree in life sciences eg biology, pharmacy, biotechnology.
  • Fluency in spoken and written French and English.
  • Knowledge, understanding and experience in the legislations and field would be an added value.
  • Some experience working in a quality/compliance/regulatory environment in pharma/medical device (1 year’s exposure), advantageous.

Required skills

  • Ability to work under stress and meet deadlines.
  • Excellent computer skills which includes working on electronic databases and good knowledge of MS office applications.
  • Good knowledge and proven application of administration processes and systems.
  • Analytical skills
  • Results oriented, good attention to detail and problem-solving skills.
  • Able to work independently and self-discipline skills.
  • Excellent prioritization and time management skills.
  • Effective administration skills, good planning and organizing skills.
  • Must use initiative, be proactive and have good follow-up skills.
  • Interpersonal and communication skills.

Location : St-Sulpice

Starting date : ASAP

If you think you fit this position, please send a CV and a cover letter.

Please note that incomplete applications will not be considered.