Data de publication: Apr 14 2025
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, 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 est un employeur prônant l'égalité des chances en matière de diversité et d'inclusion. Nous accueillons les candidatures de tous les individus qualifiés qui postulent aux opportunités de carrière que nous proposons. GSK s'engage à prendre en charge les personnes présentant des handicaps. Si vous avez besoin de dispositions particulières à n'importe quelle étape du processus de candidature ou si vous désirez d'autres informations sur nos politiques de dispositions particulières, veuillez nous contacter à l'adresse canada-recruitment@gsk.com. Veuillez ne pas envoyer de curriculum vitae à cette adresse électronique, mais postulez plutôt à cette offre d'emploi via le processus de candidature en ligne.
Avis important à l'attention des cabinets de recrutement/agences d'intérim
GSK n'accepte pas de candidatures recommandées provenant des cabinets de recrutement/agences d'intérim pour les postes à pourvoir sur ce site. Tous les cabinets de recrutement/agences d'intérim doivent contacter le service des ressources humaines ou les Achats de GSK pour obtenir une autorisation écrite préalable avant de présenter des candidats à GSK. L'obtention d'une autorisation écrite préalable est une condition préalable à tout accord (oral ou écrit) entre le cabinet de recrutement/l'agence d'intérim et GSK. En l'absence d'une autorisation écrite, toute action de la part du cabinet de recrutement/l'agence d'intérim sera jugée comme ayant été effectuée sans le consentement ou l'accord contractuel de GSK. GSK ne pourra par conséquent pas être tenu responsable des frais résultant de telles actions ou des coûts découlant de candidatures recommandées par des cabinets de recrutement/agences d'intérim pour les offres d'emploi publiées sur ce site.