Regulatory Affairs Mgr

Job description

Nombre del sítio: Canada - Ontario - Mississauga
Fecha de publicación: Feb 26 2024

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, 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.

Qualifications Required:

·  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
·  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
·  Canadian CMC Regulatory experience with small molecules, vaccines, and other biologics is an asset

Preferred Qualifications

·  Graduate degree and/or Post-Graduate Certificate in Regulatory Affairs.

GSK es una empresa que cree en la igualdad de oportunidades y que se compromete con la diversidad y la inclusión. Aceptamos las solicitudes de todas las personas cualificadas para solicitar nuestras oportunidades profesionales. GSK se compromete a realizar adaptaciones para las personas con discapacidad. Si necesita una adaptación en cualquier fase del proceso de solicitud o desea más información sobre nuestras políticas de adaptación, contacte con nosotros en canada-recruitment@gsk.com . No envíe currículums a esta dirección de correo electrónico. Presente su solicitud a través del proceso de solicitud en línea de esta publicación.

Aviso importante a las empresas o agencias de empleo

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