CMC Consultant (m/w/d) in Munich

Is strong team spirit very important to you? Are you an enthusiastic natural scientist and have a fable for meticulous and super-precise work? Your fingers tingle when you hear the word drug approval? Can you identify yourself 100% with the role as a quality expert in the team? If you feel like experiencing this with an international and leading consultancy offering a wide range of services in the field of regulatory affairs, then you've come to the right place!

What are your tasks as CMC Consultant?

• Provide advice to clients on quality aspects of drug development and regulatory requirements, in close collaboration with cross-functional experts from the team
• Ensure that the content of CMC work-packages and documentation are phase appropriate, meet regulatory expectations and enable approval of regulatory submissions
• Preparation of quality sections for MAA and BLA/NDA as well as for IMPD and IND
• Perform gap analyses of client-provided packages. Identify critical CMC development issues and develop strategies for their resolution
• Support due diligence processes
• Prepare briefing packages for agency meetings (e.g. scientific advice, oral explanation, EoP2) and conduct such meetings together with the client
• Management of operational and strategical aspects with CDMOs
• Coordination of filing activities within the cross-functional team and with contributing parties
• Continued observance of regulatory guidance and regulations

Which requirements are needed as CMC Consultant?

• D. or master's degree in Pharmacy, Chemistry, Biopharmaceuticals, Biochemistry, Biology or comparable
• At least five years in a scientific/technical CMC development or regulatory affairs function
• Experience with regulatory filings (IND/IMPD, BLA/NDA/MAA).
• Excellent communication and negotiation skills in English. German language skills are a plus
• Experience with CMC and regulatory requirements for all development stages, from pre-clinical to Phase III or commercial
• Highly motivated team player with strong interpersonal abilities
• Sound knowledge of Microsoft Office applications
• Willingness to travel moderately (Meetings with clients, agencies or CMOs)

What can you expect as CMC Consultant?

• Professional and friendly working environment
• Modern office space in the south of Munich
• Working with a dedicated small and effective team
• Very competitive salary
• Attractive bonus system tailored to your expertise and business success

About the client?

Our client is a leading consultancy for regulatory affairs, supporting small and big biotech and pharmaceutical companies in all phases of drug and device development, from defining the right strategy to submitting the marketing authorisation application, regulatory maintenance etc. All consultants have gained many years of experience within the industry and have know-how and proficiency in the various disciplines required for drug development. The company was founded in 2002 and delivered quality service to more than 500 clients in Europe, North America, Japan, Australia and Asia.

Contact for application:

• E-Mail: gotzler@sciproglobal.de
• Tel: +49 (0)89 / 21 09 49 06
• Xing: https://www.xing.com/profile/Sebastian_Gotzler/portfolio?sc_o=mxb_p
• LinkedIn: https://www.linkedin.com/in/sebastian-gotzler-39617a15a/