Oncology Regulatory Affairs Lead

Biopharma Careers

Upper Providence (Delaware County)

On-site

USD 139,000 - 231,000

Full time

14 days+

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Benefits offered by this job

Annual bonus

Long-term incentive program

Health insurance

Retirement benefits

Job summary

GSK is seeking an Associate Director Regulatory Affairs, Oncology to develop and execute regulatory strategies for global and regional assets, ensuring alignment with Medicines Development strategy and local requirements. You will lead interactions with regulatory authorities and collaborate with EDT/MDT and commercial teams to optimize labeling and compliance.

The role requires experience across drug development stages, strong leadership in regional submissions, and knowledge of global/regional

Qualifications

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 and ideally knowledge of other key Agency processes globally.

Responsibilities

Proactively develop regulatory strategy that will deliver the needs of the local region(s), taking into account the needs of other regions globally.
Implement the regional strategy(s) in support of the project globally.
Lead regulatory interactions and review processes in local region.
Ensure appropriate interaction with global/regional counterparts and commercial teams in local region.
Ensure compliance with global/ regional requirements at all stages of product life.
Ideally assess precedent, regulatory intelligence and competitive environment from a regulatory perspective for the region and the impact this will have on the regulatory strategy for an asset.