Global Regulatory Affairs Scholar (1 of 2)
Johnson & Johnson Innovative Medicine
Spring House, PAFresher2h agovia LinkedIn
About the Role
Johnson & Johnson's Innovative Medicine division is seeking a Global Regulatory Affairs Scholar. This is a two-year experiential fellowship program designed for recent university graduates to gain hands-on professional development within a leading healthcare company.
Key Responsibilities
- Develop a broad understanding of the global drug development lifecycle and related strategies for engaging health authorities.
- Learn the laws, guidance’s, and regulatory requirements for drugs and combination products while staying aligned with the organization’s goals.
- Tackle real-world projects that build leadership presence, strengthen influence with stakeholders, and enhance collaboration, problem-solving, and presentation skills.
- Grow professional network and cross-functional exposure by working with different teams.
- Participate in internal and external meetings to support role responsibilities.
- Own a complex capstone project and present results to GRA senior leaders and internal partners.
Requirements & Tech Stack
- Bachelor's degree (B.S. or B.A.) from a 4-year university program.
- Pursuing or earned an advanced degree (PhD/PharmD) in a scientific, technology, or engineering-related field, with planned graduation by May 2027. Examples include biomedical engineering, data analytics/applied statistics, quantitative modeling in biology, pharmacy, or other healthcare sciences.
- This position is suited for candidates with early professional experience looking to develop careers in regulatory affairs.
- Strong academic track record.
- Fundamental understanding of pharmaceutical drug development is preferred.
- Knowledge of current Food and Drug Administration (FDA) regulations, guidelines, and submission requirements is desired.
- Proven leadership capabilities in an organizational setting (campus/community activities) is desired.
- Ability to work independently and as part of a group, with curiosity and flexibility.
- Self-motivated, with a "can do" approach and courage to speak voice and suggest innovative ideas.
- Creative problem solver, with an interest in exploring the international context of healthcare systems and technology.
Qualifications
- Analytical Reasoning
- Business Behavior
- Business Writing
- Communication
- Confidentiality
- Data Reporting
- Detail-Oriented
- Legal Support
- Medicines and Device Development and Regulation
- Problem Solving
- Product Licensing
- Regulatory Affairs Management
- Regulatory Compliance
- Regulatory Development
- Regulatory Environment
- Risk Assessments
- Teamwork