Site Name: GSK HQ, Baar Onyx, UK - Hertfordshire - Stevenage
Posted Date: Nov 15 2024
At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease.
Science and technology are coming together in a way they never have before, and we have strong tech-enabled capabilities that allow us to build a deeper understanding of the patient, human biology and disease mechanisms, and transform medical discovery. We are revolutionising the way we do R&D. We're uniting science, technology and talent to get ahead of disease together.
Are you passionate about regulatory strategy and oncology? Within the Oncology space, we are in a period of very dynamic growth, as we continue to expand and develop our pipeline and portfolio. We are looking for a driven and motivated Global Regulatory Affairs Director who will be instrumental in developing and executing global and regional regulatory strategies for assigned assets in our growing oncology portfolio. Your efforts will ensure compliance with regulatory requirements while optimising the development programme to meet the needs of patients in global markets.
Key Responsibilities: Strategic Development: Act as the Global Regulatory Lead (GRL), or collaborate as a regional lead with the GRL, and Global Regulatory Therapeutic Area (TA) Head to develop and implement robust regional regulatory strategies that align with the Medicines Development Strategy and Integrated Asset Plan.Matrix Leadership: Engage in extensive matrix working within GSK, including with senior management, and represent GSK with local regulatory agencies to secure optimal labelling based on available data.Global Collaboration: Work closely with global and regional counterparts, as well as local commercial teams, to ensure a harmonized approach to regulatory submissions and approvals.Compliance: Maintain compliance with global and regional regulatory requirements throughout the product lifecycle.Regulatory Intelligence: Conduct regulatory intelligence activities to assess the competitive landscape and its impact on regulatory strategies.Basic Qualifications & Skills: Bachelor's degree in biological or healthcare scienceExtensive experience in pharmaceutical industry Regulatory AffairsProven track record of interactions with Health AuthoritiesCapable of leading development, submission and approval activities in different region(s) globallyAbility to develop necessary specialist knowledge for the product in a specific oncology disease area.Preferred Qualifications & Skills: Advanced Scientific Degree (PhD, MD, PharmD).Knowledge of the drug development process in regulatory affairs.Awareness of global regulatory processes, including submission and approval activities.Understanding of clinical trial and licensing requirements.Strong matrix working skills with the ability to facilitate dialogue and contribute to strategic changes.Creative problem-solving abilities with a balanced approach to regulatory expectations and compliance.Ability to coach and mentor others.Closing Date for Applications – 31 Jan 2025 (COB) Please take a copy of the Job Description, as this will not be available post closure of the advert.
When applying for this role, please use the 'cover letter' of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above.
As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.
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