Global Regulatory Affairs Director - Oncology
Site Name: GSK HQ, Baar Onyx, Brussels, La Plaine TSA, Poznan Grunwaldzka, UK - Hertfordshire - Stevenage, Warsaw Rzymowskiego 53
Posted Date: Dec 3 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.
Are you passionate about regulatory strategy and oncology? 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:
* 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.
* Engage in extensive matrix working within GSK and represent GSK with local regulatory agencies to secure optimal labelling based on available data.
* Work closely with global and regional counterparts, as well as local commercial teams, to ensure a harmonized approach to regulatory submissions and approvals.
* Maintain compliance with global and regional regulatory requirements throughout the product lifecycle.
* 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 science.
* Extensive experience in pharmaceutical industry Regulatory Affairs.
* Proven track record of interactions with Health Authorities.
* Capable of leading development, submission and approval activities in different region(s) globally.
* Ability 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.
At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people over the next 10 years. 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.
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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