Posted Date: Apr 11 2025
Are you interested in shaping the future of healthcare? We are seeking a dynamic and experienced Manager, Regulatory Policy and Advocacy with strong relationship management skills and passionate about driving change, to join our team. You will be playing a pivotal role in enabling innovative development, accelerated registration and effective life cycle management of GSK’s portfolio through exceptional advocacy of regulatory policies and engagement of external stakeholders. You lead efforts to monitor and respond to changes in the regulatory environment, working collaboratively externally, locally and globally, on ways to overcome regulatory policy barriers as well as identify opportunities to support the creation of an environment conducive to bringing and maintaining innovative products to Canadian patients.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…
- 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
Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
- 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.
- 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
- Demonstrated ability to develop effective policy strategies aligned with business objectives
- Excellent oral and written communication skills including the ability to present information and contribute ideas in small and large groups
- Excellent negotiation skills
- Fully developed project management skills
- Must act with integrity and demonstrate a strong and effective risk management perspective
- Proactive and seeks to constantly learn and develop, ensures that skills meet changing business needs
- Strong commitment to quality mindset
- Strong computer literacy and computer skills including Word, Excel, PowerPoint, Outlook
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
- Advanced degree in Pharmacy, Chemistry, Biology, Medicine, or similar discipline.
- Well-established Canadian regulatory network is an asset
- Working knowledge of global regulatory agencies and their practices
- Experience at a large global pharmaceutical or vaccines company
- Familiarity with key international regulations and guidelines is an asset
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:
- Agile and distributed decision-making – using evidence and applying judgement to balance pace, rigour and risk
- Managing individual and team performance.
- Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
- Implementing change initiatives and leading change.
- Sustaining energy and well-being, building resilience in teams.
- Continuously looking for opportunities to learn, build skills and share learning both internally and externally.
- Developing people and building a talent pipeline.
- Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation.
- Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally.
- Budgeting and forecasting, commercial and financial acumen.
*This is a job description to aide in the job posting, but does not include all job evaluation details.
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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 committed to diversity and inclusion. We welcome applications from all qualified individuals to apply to our career opportunities. 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 canada-recruitment@gsk.com. Please do not send resumes to this e-mail and instead apply through the online application process of this posting.
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