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Regulatory Affairs Specialist

2 months ago

Toronto, Ontario, Canada Johnson & Johnson Full time
Join Our Team as a Regulatory Affairs Intern

We are seeking a highly motivated and detail-oriented individual to join our Regulatory Affairs team as an Intern. As a Regulatory Affairs Intern, you will play a key role in supporting the registration of new pharmaceutical products and ensuring compliance with Health Canada regulatory requirements.

Key Responsibilities:
  • Assist in the preparation and compilation of regulatory submissions, including New Drug Submissions (NDSs), Supplemental New Drug Submissions (SNDSs), and other submissions to support the lifecycle management of pharmaceutical products.
  • Develop responses to Health Canada queries in relation to clinical efficacy and safety, clinical pharmacology, biopharmaceutics, and preclinical subject matter.
  • Collaborate with internal partners to ensure delivery of regulatory affairs activities to meet strategic business objectives and goals.
  • Assist with the department's effort to operationalize and improve critical departmental processes.
Requirements:
  • Bachelor's degree in the biological or life sciences. An advanced university degree (MSc, PhD) in biological sciences or life sciences is preferred.
  • Enrolled in a Post Graduate Certificate or Degree program related to Regulatory Affairs.
  • Strong computer skills, including knowledge of databases and Excel.
  • Strong problem-solving and analytical skills.
  • Strong teamwork and communication skills (oral and written).
  • Project management skills and ability to handle multiple priorities.
  • Knowledge of the drug development process is highly desirable.
  • Knowledge of Canadian drug laws, regulations, guidelines, and policies, and the Health Authority organizational structure and processes for the review and approval of drug submissions is highly desirable.
About Johnson & Johnson

Johnson & Johnson is a global healthcare leader that is committed to helping people live healthier, more fulfilling lives. We are a company that values diversity, equity, and inclusion, and we are dedicated to creating a culture of belonging where all perspectives, abilities, and experiences are valued.

We are proud to be an Affirmative Action and Equal Opportunity Employer, and we are committed to providing a work environment that is free from discrimination and harassment. We welcome applications from diverse candidates and encourage you to apply if you are passionate about making a difference in the lives of others.