Nom du site: Mississauga Milverton Drive
Data de publication: Jan 15 2025
If you are an experienced Regulatory Affairs professional with a commitment to excellence and creativity, we want to hear from you! As a Regulatory Affairs Manager at GSK, you will manage a portfolio of products and collaborate with a diverse range of global and local cross-functional teams. You will define and implement regulatory strategies to ensure our innovative products achieve rapid market authorization. Join a dynamic environment where your skills and dedication will be valued and rewarded.
Key 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, 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, supply continuity, 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:
- 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
- Must possess a thorough understanding of the Canadian Food & Drug Regulations, relevant guidelines and policies
- 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
- 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
- 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 computer literacy and computer skills including Word, Excel, PowerPoint, Outlook, Veeva Vault
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
- Graduate degree and/or Post-Graduate Certificate in Regulatory Affairs.
Why GSK?
Our values and expectations are at the heart of everything we do and form an important part of our culture.
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
- Operating at pace and agile decision-making – using evidence and applying judgement to balance pace, rigor and risk.
- Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
- Continuously looking for opportunities to learn, build skills and share learning.
- Sustaining energy and well-being.
- Building strong relationships and collaboration, honest and open conversations.
- Budgeting and cost-consciousness.
#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.
