Job Description
This role involves planning, preparing and managing analytical-related regulatory filings across our diverse portfolio.
The successful candidate will collaborate with cross-functional teams to ensure the timely and high-quality delivery of filing-related documentation.
Key Responsibilities
* Lead the planning, preparation and management of analytical-related regulatory filings across the portfolio.
* Assist in compiling and reviewing analytical documentation required for regulatory filings.
* Work closely with cross-functional teams to ensure seamless delivery of high-quality analytical strategies.
* Maintain clear and accurate tracking of filing-related activities and milestones.
* Contribute to the preparation and implementation of analytical control strategies.
Key Qualifications and Requirements
* Working knowledge of Analytical Strategy and Lifecycle principles and concepts.
* Hands-on experience with a broad range of assays for testing and characterising biological products.
* Understanding of method qualification and validation.
* Proven ability to collaborate effectively with remote colleagues and within a matrix organisational structure.
* Strong analytical and writing skills.