Quality and Regulatory Affairs Analyst

Posted Date: 10-January-2020

Quality and Regulatory Affairs Analyst

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We are adding a new position to our Montreal office and are seeking candidacies for a:
Quality and Regulatory Affairs Analyst
This position includes direct involvement of Quality troubleshooting. Reporting to the RA/QA manager, the successful candidate will have working knowledge of Canadian regulatory and quality experience, and must be able to manage and coordinate pharmacovigilance for Canada, US and Beiersdorf global, including for Nivea and Coppertone.

Quality Assurance responsibilities (45%)

  • Approving/editing first product Quality releases for all BDF Canada DIN and NHP products
  • Managing CAPAs
  • Preparing monthly quality report that reflect consumer and customer complaints, OSQ and Audit Plan
  • Assisting in implementing regional QA projects
    Helping ensure that Global/Regional BDF QA requirements are implemented in LSP and VAS
  • Assisting in performing quality store checks on an ongoing basis, documenting deficiencies and preparing reports and assisting Quality manager in the quality on shelf corporate initiative
  • Evaluating destruction criteria for DIN and NHP returns through Phoenix
  • Contributing to continuous Improvement initiatives and participating in risk identification and contingency planning activities

Regulatory Affairs responsibilities (35%)

  • Reviewing DIN/NHP/cosmetic and medical devices labels for Regulatory compliance for RA Manager to approvals
  • Reviewing advertising materials including print, digital etc. for RA manager approval
  • Assisting in putting together licensing submission documents and compiling and preparing
  • DIN/NHP guidance’s for launches
  • Assisting in managing claims support and interfacing with Hamburg, US and Coppertone research and development
  • Assisting in training BDF employees and external agencies: Stafford (Consumer Affairs), 1M2S (PR Agency) for onboarding and annual refresher training

Pharmacovigilance responsibilities (20%)

  • Handling pharmacovigilance for US and Canada and supporting the RA/QA Manager in the investigation of consumer complaints and/or adverse events
  • Processing of individual case safety reports, and basic knowledge in aggregate reports, ICSRs, DSURs, in compliance with Regulatory authorities
  • Proficiency in using MedDRA and WHO drug dictionary to correctly code adverse event and work with external medical advisor to get medical insight on safety and efficacy of products
  • Proficiency in writing concise medical narratives and preparing Med Watch and CIOMS forms

Do you possess…

  • University degree in Science or relevant field of study and ideally a post graduate degree in Regulatory Affairs
  • 1-2 years FDA and Health Canada submission experience (includes NDS, SNDs, NC, DINA, CTA, Medical Device submissions)
  • Working knowledge of and ability to interpret the Canadian Food and Drugs Act and Regulations and Medical Device Regulations as well as Health Canada policies and guidelines
  • Strong technical knowledge of pharmaceutical manufacturing, quality assurance, GMP, ISO, ICH Guidelines
  • Good written and verbal communication skills, excellent interpersonal and collaboration skills
  • Strong organization skills and ability to prioritize workload
  • Accuracy and attention to detail, as well as an ability to deal with ambiguity
  • Proficient computer skills including MS Office Applications
  • Ability to work independently and self-motivated to achieve results
  • Strong critical thinking and problem solving skills
  • Intellectual curiosity for keeping abreast of changing regulations and policies to ensure compliance
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