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Regulatory Affairs Lead

2 weeks ago

Mississauga, Ontario, Canada GlaxoSmithKline Full time

About Us

At GlaxoSmithKline, we are a global biopharma company that unites science, technology, and talent to get ahead of disease together.

We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas.

Job Summary

We are seeking an experienced Regulatory Affairs professional to join our team as a Regulatory Affairs Manager. The successful candidate will manage a portfolio of products, collaborate with cross-functional teams, and develop regulatory strategies for rapid approvals.

Key Responsibilities

  • Develop regulatory strategies for rapid approvals with optimal labeling for products within therapy or for submissions within specialization area.
  • Accountable for a portfolio of products, including the preparation, filing, and approval of regulatory submissions to aggressive targets.
  • Ensure compliance with applicable regulations, industry codes, and guidelines in alignment with business needs.
  • Build trust with regulatory authorities to improve submission approval times, achieve competitive labeling, and resolve product-related issues.
  • Communicate with and influence multiple functions to achieve regulatory objectives.
  • Identify and respond to issues related to assigned projects and/or products.
  • Interpret Canadian regulations, guidelines, and policies as they apply to regulatory activities.
  • Mentor junior staff.

Basic Qualifications

  • B.Sc. in life science or relevant scientific field.
  • Extensive Canadian regulatory affairs experience leading multiple submissions at all stages of the product lifecycle.
  • Thorough understanding of the Canadian Food & Drug Regulations, relevant guidelines, and policies.
  • Thorough understanding of drug development and commercialization processes.
  • Innovative problem solver and decision maker who can apply continuous improvement techniques.
  • Demonstrated ability to develop effective regulatory strategies aligned with commercial objectives.
  • Working knowledge of global regulatory agencies and their practices.
  • Excellent oral and written communication skills.
  • Good influencing and relationship management skills.
  • Excellent negotiation skills.
  • Fully developed project management skills.