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Are you experienced in Regulatory CMC and are you able to drive and develop regulatory strategies for CMC activities? Then Symphogen is looking for you as their next member of the Global Regulatory Team!
As Sr CMC Regulatory Manager at Symphogen, you will be a member of the Global Regulatory Team, where you will provide input to the regulatory strategy as well as work closely with CMC colleagues and perform regulatory evaluation and impact assessment of e.g. drug substance/drug product manufacturing process changes.
You will report directly to the Deputy Head of Regulatory CMC Department, and with a dotted reporting line to Director IND & Phase 1.
You will drive regulatory CMC activities during development and planned global submissions of
MAAs, NDAs, and BLA, and be responsible for the quality documentation of their IND and CTA submissions as well as their Marketing Authorisation Applications (MAA) and life-cycle management for biologics.
Your main tasks are:
Specific quality/regulatory activities include:
Your qualifications are a minimum of 5 years of relevant CMC/Regulatory CMC pharmaceutical industry experience. You possess strong regulatory strategy skills and an ability to thrive in a multi-faceted environment, and you are overall knowledgeable in ICH, FDA, and EMA guidelines and requirements.
You have a Master’s Degree in Natural Science or a related field of study.
You are a person with an open and problem-solving mindset, who has a pragmatic approach and can demonstrate critical thinking with attention to detail. You are fluent in English, and possess great communication skills, verbally as orally.
Symphogen offers a challenging and versatile job in an innovative, flexible, focused, and committed biotech environment. The environment is marked by strong cross-functional teamwork, with room for diversity, individual performance and development, and most important, passionate, and fun colleagues! As an employee in Symphogen, you will be part of a highly engaged and inspiring organization, and you will have the opportunity to influence job content and set your footprint on improving the lives of cancer patients.
Traveling: Approx. 10 days a year.
Domicile: In reasonable distance to the office in Ballerup.
For more details about the job or the company, please contact CEO, Jørn Duhn on M: +45 21 75 19 25, Client Manager, Gert Vium Andersen on M: +45 42 95 08 83, or Research Consultant, Emma Dahl on M: +45 51 43 43 17. All applications must be in English and are treated confidentially.