Therapy Area Regulatory Affairs Manager – Oncology

Site Name: Canada - Ontario - Mississauga
Posted Date: Sep 3 2021

Therapy Area Regulatory Affairs Manager - Oncology

Primary Responsibilities:

• Develops regulatory strategies for rapid approvals of submissions with optimal labelling for products within therapy area
• Accountable for a portfolio of products, including the preparation, filing and approval of regulatory submissions (NDSs, SNDSs, CTAs, etc.) to aggressive targets
• Ensures compliance with applicable Health Canada, industry, and GSK codes and guidelines in alignment with business needs
• Builds trust with Health Canada contacts to improve GSK submission approval times, achieve competitive labelling, and resolve product related issues impacting submissions or compliance activities
• Communicates with and influences multiple local and global functions to achieve regulatory objectives
• Identifies and responds to issues related to assigned projects and/or products
• Interprets Canadian regulations, guidelines and policies as they apply to GSK regulatory activities
• Mentors junior staff

Qualifications Required:

• B.Sc. in life science or relevant scientific field (e.g. pharmacology, toxicology, chemistry)
• Extensive Canadian regulatory affairs experience leading multiple submissions at all stages of the product lifecycle, including developing the regulatory strategy for New Drug Submissions and line extensions, with specific experience in oncology.
• Must possess a thorough understanding of the Canadian Food & Drug Regulations, relevant guidelines and policies
• Must possess a thorough understanding of drug development and commercialization process
• Highly innovative (strategic and functional), and creative problem solver and decision maker who can apply continuous improvement techniques to gain efficiencies in submission preparation, product approval process, and resolving issues
• Agile and able to effectively navigate change
• 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 the ability to present information and contribute ideas in small and large groups
• Good influencing and relationship management skills
• Excellent negotiation skills
• Fully developed project management skills
• Must act with integrity and demonstrate a strong and effective risk management perspective
• Ability to provide and receive feedback, raise issues, share experiences and lessons learned
• Proactive and seeks to constantly learn and develop, ensures that skills meet changing business needs
• Fosters strong team collaboration with the ability to engage constructively with others and demonstrate a positive mindset. Open to diverse ideas, styles and perspectives.
• Strong commitment to quality mindset
• Strong computer literacy and computer skills including Word, Excel, PowerPoint, Outlook

Preferred Qualifications:

• Graduate degree and/or Post-Graduate Certificate in Regulatory Affairs

• LI-GSK

GSK is an equal opportunity employer committed to diversity and inclusion. We welcome applications from all qualified individuals to apply to our career opportunities. GSK is committed to accommodating persons with disabilities. If you need accommodation at any stage of the application process or want more information on our accommodation policies, please contact us at canada-recruitment@gsk.com. Please do not send resumes to this e-mail and instead apply through the online application process of this posting.

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