A Bethesda / Munich based and NASDAQ traded Drug Discovery company develops antibody based therapeutics for the treatment of cancer, autoimmune- and inflammatory diseases. With its more than 120 professionals in both sites it combines excellent science with a highly, integrated development organization. It complements inhouse competence by a network of academic and industrial partners.
Life Science professionals in all of Central Europe wish to work for this company which is located in one of the most popular areas in Europe: 45 minutes by car to Garmisch, various lakes and castles in bycycling distance. Oktoberfest almost in walking distance.
Tasks:
The Munich based individual covers all the regulatory aspects of all CMC affairs in this prominent Bethesda / Munich based and NASDAQ traded drug discovery company. Specifically, this manager:
Helps shaping all activities in product development and specifically in process development projects
Recognizes early on likely issues and searches for solutions
Represents the CMC function of the company as a member of the various project teams
Carries the responsibility for a successful and timely supply of the documents required for regulatory approval (NDA / IMPDs, MAA/BLAs). This Director is being assisted by the CMC project management and documentation teams.
Carries the responsibility to coordinate and to assist in preparing and filing the regulatory documentation and related documents
Prepares scientific advisory meetings with the authorities to discuss CMC affairs
Profile:
Degree in Pharmacy, Biotechnology, Biology, Chemistry or related science
Solid background skills regarding CMC for biologics
Several years of job experience in the area of Regulatory Affairs of biopharmaceuticals and specifically CMC
Several years of team work within the drug discovery industry
Experience in managing small and effective teams
Solid experience in Regulatory Affairs for CMC and its documentation
Convincing personality, strong communication skills and good team interaction
Quick grasp on the issues and entrepreneurial attitude
Fluency in English to address the international challenges, German a nice to have
Experience overseas advantageous but no prerequisite
