What are the responsibilities and job description for the Associate Director, Oncology GRA position at GlaxoSmithKline?
Site Name : USA - Pennsylvania - Upper Providence, Durham Blackwell Street, Rockville Vaccines, Waltham
Posted Date : Feb 24 2025
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.
As an Associate Director of Global Regulatory Affairs, you will ensure the development and execution of global and / or regional regulatory strategies for assigned assets. These strategies will be in alignment with the Medicines Development Strategy / Integrated Asset Plan, ensuring compliance with internal GSK processes and policy as well as appropriate regulatory requirements. The ultimate goal is to deliver the best possible labelling that meets the Medicine Profile, commensurate with the available data.
You will engage in extensive matrix working within GSK up to the VP level and represent GSK with local regulatory agencies.
In this role you will
- Be accountable to the Global Regulatory Lead (GRL) and Global Regulatory Therapeutic Area (TA) Head for the development of appropriate regional regulatory strategies and their delivery according to plans.
- Collaborate with the Early / Medicine Development Team (EDT / MDT) or GRL to ensure a robust regulatory strategy is in place to support the development program and meet the needs of key markets.
- Work closely with local / regional commercial teams to secure the best possible labelling commensurate with the available data.
- Lead interactions with local / regional regulatory authorities.
- Proactively develop regulatory strategies that meet the needs of the local region(s), while considering the needs of other regions globally. Implement regional strategies in support of global projects.
- Ensure compliance with global / regional requirements at all stages of the product life cycle.
Basic Qualifications & Skills :
Preferred Qualifications & Skills :
Why GSK?
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.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or 1 801 567 5155 (outside US).
GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles.
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