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.
Assess analytical risks, monitor trends and evaluate method performance (lifecycle management).
Mentor and develop Junior and Mid-level analysts.
Support strategic decisions related to equipment, technologies and analytical investments.

Bachelor's degree in Pharmacy, Chemistry or a related field.
Minimum of 7–8 years' experience in analytical development.
In-depth knowledge of analytical validation, QbD, data integrity and regulatory affairs.
Strong technical leadership, decision-making skills and systems thinking.

Senior Analytical Development Analyst

Key skills