Regulatory Affairs Specialist

3 weeks ago

Mississauga, Ontario, Canada 837 GlaxoSmithKline Inc. Full time
Key Accountabilities/Responsibilities:
  • Develop and implement regulatory strategies to ensure compliance with Health Canada regulations and guidelines.
  • Prepare and submit regulatory documents, including NDSs, SNDSs, CTAs, and NCs, to meet aggressive targets.
  • Ensure compliance with applicable codes and guidelines, including Health Canada and industry standards.
  • Build and maintain relationships with Health Canada contacts to improve submission approval times and achieve competitive labelling.
  • Communicate and influence multiple local and global functions to achieve regulatory objectives.
  • Identify and respond to issues related to assigned projects and/or products.
  • Interpret Canadian regulations, guidelines, and policies to inform regulatory activities.
  • Mentor junior staff and provide guidance on regulatory affairs.
Qualifications Required:
  • Bachelor's degree in a life science or relevant scientific field.
  • Extensive Canadian regulatory affairs experience, including leading multiple submissions at all stages of the product lifecycle.
  • Thorough understanding of the Canadian Food & Drug Regulations, relevant guidelines, and policies.
  • Understanding of drug development and commercialization processes.
  • Highly innovative and creative problem solver with excellent decision-making skills.
  • Agile and able to navigate change effectively.
  • 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, including presentation and group contribution.
  • Good influencing and relationship management skills.
  • Excellent negotiation skills.
  • Fully developed project management skills.
  • Strong risk management perspective and ability to act with integrity.
  • Ability to provide and receive feedback, raise issues, and share experiences and lessons learned.
  • Proactive and committed to continuous learning and development.
  • Strong team collaboration and positive mindset.
  • Strong commitment to quality mindset.
  • Strong computer literacy and skills in Word, Excel, PowerPoint, and Outlook.

Why GSK?

GSK is a global biopharma company with a special purpose – to unite 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 (infectious diseases, HIV, respiratory/immunology, and oncology).

Our success depends on our people. We want GSK to be a place where people feel inspired, encouraged, and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing.

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