Dr. Danny Bartholome

The position involves the lead the regulatory affairs department in the German country organization of the Sandoz group consisting of 50 to 60 employees. Filing of variations and handling of renewals as well as the national phase of MR/DCPs are the responsibilities. The update of German SmPC/PIL/Labeling and release of advertising material covers the most workload. We maintain thousends of marketing authorizations and file approx. several thousends of variations per year.

Planning and execution of several hundred new submissions in the CIS/SEE region per year. By far most important market is Russia. The position has strategical and political aspects as well as the responsibility to acquire in-deep regulatory information and provide it to the entire organization.

CMC Lifecycle Management of marketing authorizations world wide. The department is located at the manufacturing site to enable a deep and effective network to the production unit. This ensures the development of the "ready-for-production-dossier" and a most effective dossier maintenance over the entire life-cycle of the product. As team leader I had leadership responsibility of approx. 10 associates including graduates and administrators.

CMC responsibility for the dossier maintenance for a certain set of products over the entire life cycle. This includes variations, renewals , new submissions and deficiency letter handling with a world wide scope (excluding US).

Organic and Makromolecular Chemistry Topic: Investigations on Synthesis and Reactions of Polyarylenes with Triphenylmethylchromophores in the Main Chain

Organic Chemistry Macromolecular Chemistry Environmental Chemistry