Manager, Oncology Therapeutic Group, Global Regulatory Affairs
Sector: Health and Medical
Role: Manager
Contract Type: Permanent
Hours: Full Time
Site Name: UK - London - New Oxford Street, Baar Onyx, UK - Hertfordshire - Stevenage
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 a driven and motivated regulatory affairs professional? As a Global Regulatory Affairs Manager at GSK, you will play a pivotal role in developing and executing global and regional regulatory strategies for our assets. Your efforts will ensure that our development programs meet the needs of key markets and align with the Medicines Profile. You will be accountable to the Global Regulatory Lead (GRL) and Global Regulatory Therapeutic Area (TA) Head, ensuring timely submission and approval of clinical trial applications.
In this role you will:
* Regulatory Strategy: Proactively develop or implement regulatory strategies to ensure the submission and approval of clinical trial applications and other deliverables within agreed timescales.
* Cross-functional Collaboration: Ensure effective interaction with cross-functional teams, global/regional counterparts, and local operating companies.
* Compliance: Maintain compliance with global and regional regulatory requirements throughout the product lifecycle.
* Regulatory Intelligence: Assess precedent, regulatory intelligence, and the competitive environment to inform and refine regulatory strategies.
Basic Qualifications & Skills:
* Minimum of a Bachelor's degree in biological or healthcare science.
* Experience in the drug development process within regulatory affairs.
* Proven ability to manage development, submission, and approval activities in different regions globally.
* Knowledge of clinical trial requirements in at least one region (EU or US) and ideally familiarity with other key agency processes globally.
* Capacity to develop specialist knowledge for products in specific oncology disease areas.
Preferred Qualifications & Skills:
* Advanced Scientific Degree (PhD, MD, PharmD).
* Strong matrix working skills, with the ability to facilitate dialogue and idea contribution among team members.
* Proactive problem-solving skills to identify and resolve project or team issues in advance.
* Creative regulatory problem-solving capabilities, balancing agency expectations and compliance.
* A focus on continuous improvement and excellence, with the ability to challenge current processes and recommend strategic changes.
* Ability to develop networks within GSK to secure support and achieve project outcomes.
Closing Date for Applications: 31 Jan 2025 (COB)
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.
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 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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