Associate Director Regulatory Affairs, Oncology
GSK
August 07, 2026
On-site
Collegeville, PA
Corporate Functions
Role Summary
- Develop and execute global and/or regional regulatory strategy(s) for assigned assets in line with Medicines Development Strategy/Integrated Asset plan to meet key market needs and the Medicines Profile, ensuring compliance with internal GSK processes/policy and applicable regulatory requirements to achieve best possible labeling based on available data.
Key Responsibilities
- Proactively develop regulatory strategy for local region(s), considering global regional needs.
- Implement regional strategy(s) in support of projects globally.
- Lead regulatory interactions and review processes in the local region.
- Ensure appropriate interaction with global/regional counterparts and local commercial teams.
- Ensure compliance with global/regional requirements at all stages of product life.
- Ideally assess precedent, regulatory intelligence, and competitive environment (regional) and its impact on asset strategy.
Required / Basic Qualifications & Skills
- Experience of all phases of the drug development process in regulatory affairs (preferred).
- Experience leading regional development, submission, and approval activities in local region(s).
- Experience with clinical trial and licensing requirements in all major countries in the region; ideally knowledge of other key agency processes globally.
Preferred Qualifications & Skills
- Advanced Scientific Degree (PhD, MD, PharmD).
- Minimum 2 years oncology (hematology or solid tumor) regulatory affairs experience.
- Strong matrix working skills; proactive problem-solving and creative regulatory problem-solving.
- Continuous improvement mindset; ability to challenge processes and recommend strategic changes.
- Ability to develop networks within GSK.
Skills
- Business resilience, communication, digital fluency, matrix leadership, pharmaceutical regulatory compliance, regulatory strategies, resource and stakeholder management.
- Develop and execute global and/or regional regulatory strategy(s) for assigned assets in line with Medicines Development Strategy/Integrated Asset plan to meet key market needs and the Medicines Profile, ensuring compliance with internal GSK processes/policy and applicable regulatory requirements to achieve best possible labeling based on available data.
Key Responsibilities
- Proactively develop regulatory strategy for local region(s), considering global regional needs.
- Implement regional strategy(s) in support of projects globally.
- Lead regulatory interactions and review processes in the local region.
- Ensure appropriate interaction with global/regional counterparts and local commercial teams.
- Ensure compliance with global/regional requirements at all stages of product life.
- Ideally assess precedent, regulatory intelligence, and competitive environment (regional) and its impact on asset strategy.
Required / Basic Qualifications & Skills
- Experience of all phases of the drug development process in regulatory affairs (preferred).
- Experience leading regional development, submission, and approval activities in local region(s).
- Experience with clinical trial and licensing requirements in all major countries in the region; ideally knowledge of other key agency processes globally.
Preferred Qualifications & Skills
- Advanced Scientific Degree (PhD, MD, PharmD).
- Minimum 2 years oncology (hematology or solid tumor) regulatory affairs experience.
- Strong matrix working skills; proactive problem-solving and creative regulatory problem-solving.
- Continuous improvement mindset; ability to challenge processes and recommend strategic changes.
- Ability to develop networks within GSK.
Skills
- Business resilience, communication, digital fluency, matrix leadership, pharmaceutical regulatory compliance, regulatory strategies, resource and stakeholder management.