Job Description

Candidates with Solid and proven track record with Health Canada Policies and existing relationships with Health Canada in Drug and Pharma will be considered for this role.
Key Accountabilities/Responsibilities:

• Leads and supports the development of the Regulatory Advocacy and Policy External Engagement Plan, defining and implementing key tactics to influence and actively shape critical Health Canada policies to create a regulatory environment that supports delivery of GSK's pipeline and meets business objectives
• Identifies and drives opportunities for increased GSK leadership externally in alignment with business objectives
• Monitors for changes in the regulatory environment and recommends actions to mitigate or opportunities to leverage to support achievement of business objectives
• Co-ordinates commenting on and performs analyses on Regulatory policy related changes to ensure alignment with GSK position and business needs
• Engages with local or global RA functions to share updates and identify policy barriers/gaps/opportunities, including working collaboratively to develop strategies/tactics to address
• Engages externally to represents GSK on identified policy topics, including representing GSK at key regulatory agency or industry meetings
• Builds and maintains relationships and trust with a wide range of external stakeholders including regulatory agency, government and industry associations as relevant, to support the needs of the business
• Interprets Canadian regulations, guidelines and policies as they apply to GSK regulatory activities
• Serves as a policy subject expert based on in depth knowledge of key regulatory and scientific issues and mentor staff on advocacy and policy topics, external relationship building and provides input on the development of regulatory strategy to meet business objectives

Qualifications:

• B.Sc. in life science or relevant scientific field (e.g. pharmacology, toxicology, chemistry)
• Extensive knowledge and experience working in a policy role and successfully advocating for Canadian policy changes.
• Familiarity with key international regulations and guidelines is an asset
• Well-established Canadian regulatory network is an asset
• Must possess a thorough understanding of the Canadian Food & Drug Regulations, relevant guidelines and policies, and the Health Canada organizational structure and processes for the review and approval of health product submissions
• 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 policy strategies aligned with business 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 building and 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

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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.
GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law. GSK is committed to accommodating persons with disabilities. If you need accommodation at any stage of the application process or want more information on our accommodation policies, please contact us at . Please do not send resumes to this e-mail and instead apply through the online application process of this posting.
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