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