Oncology Regulatory Affairs Lead
4 weeks ago
Primary Responsibilities:
Formulates regulatory approaches to facilitate swift approvals with optimal labeling for products within the oncology sector or for submissions within the specialized area. Responsible for managing a portfolio of oncology products, including the preparation, submission, and approval of regulatory documents (NDSs, SNDSs, CTAs, NCs, etc.) to meet ambitious targets. Ensures adherence to relevant Health Canada regulations, industry standards, and GSK policies in alignment with organizational objectives. Cultivates relationships with Health Canada representatives to enhance GSK submission approval timelines, secure competitive labeling, and address product-related challenges affecting submissions or compliance efforts. Engages with and influences various local and global teams to achieve regulatory goals. Proactively identifies and addresses issues related to assigned projects and/or products. Analyzes Canadian regulations, guidelines, and policies as they pertain to GSK's regulatory functions. Provides mentorship and training to junior team members.Required Qualifications:
Bachelor’s degree in a life science or a related scientific discipline (e.g., pharmacology, toxicology, chemistry). Significant experience in Canadian regulatory affairs, leading multiple submissions throughout the product lifecycle. Comprehensive understanding of the Canadian Food & Drug Regulations, relevant guidelines, and policies. In-depth knowledge of the drug development and commercialization processes. Highly innovative and strategic thinker with strong problem-solving capabilities, adept at applying continuous improvement methodologies to enhance submission preparation, product approval processes, and issue resolution. Adaptable and capable of effectively managing change. Proven ability to devise effective regulatory strategies that align with commercial goals. Familiarity with global regulatory agencies and their operational practices. Exceptional verbal and written communication skills, with the ability to present information and share ideas in both small and large group settings. Strong influencing and relationship management abilities. Excellent negotiation skills. Well-developed project management capabilities. Must demonstrate integrity and possess a robust risk management perspective. Ability to give and receive constructive feedback, raise concerns, and share insights and lessons learned. Proactive in seeking continuous learning and development opportunities, ensuring skills align with evolving business needs. Promotes strong team collaboration, engaging constructively with others and demonstrating a positive attitude. Open to diverse ideas, styles, and perspectives. Strong commitment to quality. Proficient in computer applications, including Word, Excel, PowerPoint, and Outlook.Preferred Qualifications:
Advanced degree and/or Post-Graduate Certificate in Regulatory Affairs.About GSK:
GSK is a global biopharmaceutical organization dedicated to uniting science, technology, and talent to advance healthcare solutions. Our mission is to prevent and treat diseases through innovative vaccines, specialty medicines, and general pharmaceuticals. We focus on the science of the immune system and leverage new technologies and data to drive advancements in four core therapeutic areas: infectious diseases, HIV, respiratory/immunology, and oncology.
Our success is rooted in our people. We strive to create an environment where individuals feel inspired, valued, and challenged to reach their full potential. We are committed to fostering a workplace that promotes growth, well-being, and inclusivity. If you share our vision, we invite you to explore opportunities with us as we work together to make a meaningful impact on global health.
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