Serve as a technical authority in analytical development, defining analytical strategies, ensuring regulatory compliance, and providing technical support for methods throughout the product life cycle.
Lead high-complexity analytical development and validation projects.
Define analytical strategies for new products, reformulations and post-approval changes.
Critically evaluate regulatory requirements and international guidelines (ICH, Pharmacopoeias).
Ensure that analytical methods are stability-indicating and fit for purpose.
Act as the technical focal point during regulatory inspections and audits.
Perform critical reviews of analytical dossiers for registration and post-approval submissions.
Coordinate method transfers and support process validations.