Regulatory Affairs Manager (CMC and/or Oncology)

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About the role

Are you a curious, collaborative scientific professional who wants to build trusted relationships with oncology clinicians and help improve patient care across Canada?   GSK remains committed to achieving bold commercial ambitions for the future. By 2031, we aim to deliver £40 billion in annual sales, leveraging our existing strong performance momentum to significantly increase our positive impact on the health of billions of patients globally. Our Ahead Together strategy is centred on early intervention to prevent and alter the course of disease, thereby protecting people and supporting healthcare systems.   Our diverse portfolio consists of vaccines, specialty medicines, and general medicines.   Through continuous innovation and a dedicated focus on scientific and technical excellence, we strive to develop and launch new, groundbreaking treatments that address critical health challenges.   Key Responsibilities This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:  • 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, 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 • For Oncology : 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 • For CMC: 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   Why you? Basic Qualifications:   We are looking for professionals with these required skills to achieve our goals:  • B.Sc. in life science or relevant scientific field (e.g. pharmacology, toxicology, chemistry) • For Oncology: Extensive Canadian regulatory affairs experience leading multiple submissions at all stages of the product lifecycle • For CMC: Extensive Canadian CMC Regulatory experience leading multiple submissions at all stages of the product lifecycle.  Experience with small molecules, vaccines, and other biologics is an asset. • 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

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