Qualifications / Requirements
- Education: PhD or Master's in informatics, computer science, life sciences, or related discipline.
- Experience: 8+ years in pharma/biotech R&D focusing on Global Regulatory Affairs, regulatory operations, regulatory technology, or data product management.
- Strong track record in data product development, integration, or semantic modelling in a regulated domain.
- Experience with multi-modal regulatory data (submission, labelling, intelligence, compliance datasets).
Skills & Expertise
- Deep knowledge of Global Regulatory Affairs processes, submission pathways (e.g., eCTD), and global health authority requirements.
- Deep knowledge of data products, database design, and data transformation/mapping.
- Familiarity with metadata management, ontologies, knowledge graphs, and industry standards (e.g., IDMP, xEVMPD, ICH, eCTD).
- Strong leadership, collaboration, and communication skills; ability to translate technical strategy into business/science value.
- Demonstrated ability to influence stakeholders and drive adoption of new data capabilities across a complex organization.
Other
- Primary location: Spring House, PA (also open to Titusville, NJ).
- Requires up to 25% travel.
- Contract type: Fixed-term contract.
Property Manager (Central US) employer: Global Modern Services, Inc. (USA)
As a leading player in the pharma/biotech sector, our company offers an exceptional work environment in Spring House, PA, where innovation meets collaboration. We prioritise employee growth through continuous learning opportunities and a supportive culture that values diverse perspectives. Join us to be part of a team that is dedicated to advancing global health while enjoying competitive benefits and a commitment to work-life balance.
Contact Details:
Global Modern Services, Inc. (USA) Recruitment Team
