Mark Hindle Email & Phone Number

Gothenburg Sweden

Provides in-depth advice to development teams working on regulatory submissions and develops regulatory strategies to ensure successful approval of products for use in clinical trials and for marketing. The role has no managerial responsibilities and I do not have budget responsibilities. For additional information, I am close to retirement age and I am not looking for new opportunities. I also have my pension plans sorted out and therefore do not need financial advice. Thank you for reading this.

Mölndal, Sweden

Provides advice and guidance on CMC regulatory issues for a variety of pharmaceutical development Projects at different phases of development

Transfered from AstraZeneca R&D Charnwood (Loughborough, UK) to AstraZeneca R&D Molndal (Goteborg, Sweden) upon AstraZeneca R&D re-organisation

Responsible for analytical development from start of Phase 3 until first approvals (Brilinta project). Major achievements and responsibilities include:- Facilitated the smooth progression of the Brilinta project by working closely with other functions (Regulatory Affairs, Commercial Production Groups and other Development Teams) and by actively updating stakeholders of key project decisions;- Progressed regulatory submissions in face to face meetings with FDA, EMA (PAT team), Health Canada and Mexican regulatory authorities;- Guided the development of fast, cost-efficient and robust analytical methods for drug substance and drug product which were smoothly and successfully transferred to commercial production sites;- Influenced QbD development of Brilinta tablet manufacturing design space through close cross functional collaboration and provision of advice and analytical solutions to development issues;- Provided rapid and strategic analytical responses to regulatory questions from FDA, EMA, Health Canada, Australian TGA, Turkish Authorities, Malaysian and South Korea Authorities;- Managed the contracting out of NDA stability studies to a CRO and subsequent monitoring of stability data. Developed an excellent working relationship with the CRO that is now used as a model for other studies;- Initiated and implemented efficient cleaning verification procedures for pharnaceutical manufacturing equipment, resulting in significant time savings.

Responsible for analytical drug product aspects of development projects. Major responsibilities and achievements included:- Active participant in cross functional project team, influening key project decisions by providing high quality analytical data;- Performed analytical release of drug product batches for clinical use ensuring all GMP aspects of work were met;- Supervised and coached 2-4 staff members in all aspects of analytical chemistry to increase their ability to work independently;- Implemented solid dose automation within the analytical department by transferring manually performed methods onto automated equipment, bringing significant time savings;- Developed wide dissolution knowledge and provided guidance in the development of dissolution methods for several products.

Responsible for analysis of a wide range of drug substance and drug product samples, using a variety of analytical techniques. Built a good analytical judgment and a methodical and rigorous appraoch to method development and problem solving

Bsc, Chemistry

Education record