Regulatory Affairs Associate

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.

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Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose to unite science, technology and talent to get ahead of disease together so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns as an organisation where people can thrive.

We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory / immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive.

We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves feeling welcome, valued, and included.

Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

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