Regulatory Affairs Manager, Oncology

Key Accountabilities/Responsibilities:

• Develops regulatory strategies for rapid approvals with optimal labelling for products within therapy or for submissions within specialization area.
• Accountable for a portfolio of products, specific in the Oncology therapy area, including the preparation, filing and approval of regulatory submissions (NDSs, SNDSs, CTAs, NCs, 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 and trains junior staff.

Qualifications Required:

• B.Sc. in life science or relevant scientific field (e.g. pharmacology, medical oncology, toxicology, chemistry).
• Extensive Canadian regulatory affairs experience leading multiple submissions at all stages of the product lifecycle.
• Experience with solid tumour and/or ADC targeted cancer therapeutics regulatory reviews.
• Experience with small molecule and biologics regulatory reviews.
• 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, ensuring 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.