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Life Cycle Management Professional
vor 1 Woche
GSK is a global biopharma company that unites science, technology, and talent to get ahead of disease together. We are seeking a highly skilled Life Cycle Management Professional to join our team.
Main Objectives:
- To provide clinical pharmacology, therapeutic, and regulatory support for GSK portfolio.
- To ensure optimal application of clinical pharmacokinetic (PK), pharmacodynamic (PD), and modelling & simulation (M&S) principles towards efficient evidence generation for the registration and life-cycle management of medicinal products.
Key Responsibilities:
- Integration of clinical pharmacology and PKPD principles into clinical development and life-cycle management plans and product strategies.
- Support accelerated regulatory filing activities across multiple regions/markets, with focus on country-specific requirements.
- Preparation, authoring, and review of CTD modules (e.g., 2.7.1., 2.7.2. and 2.7.5) taking into account relevant regulatory requirements for effective submissions and approval of new products, indications, and/or relevant label extensions.
Qualifications:
- PhD and/or MD degree in clinical pharmacology or similar discipline.
- Relevant experience in the application of clinical pharmacology, modelling and simulation methodologies to drug development and lifecycle management, ideally gained within a pharmaceutical company.
- Experience and understanding of regulatory guidelines, ideally demonstrated experience interacting with regulatory authorities.
