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Senior Manager Regulatory Affairs CMC

2 months ago

Cambridge, Cambridgeshire, United Kingdom MoonLake Immunotherapeutics Full time

{"h1": "Senior Manager Regulatory Affairs CMC", "p": "As a key member of MoonLake Immunotherapeutics\u2019 Clinical Development team, you will be responsible for the development, execution, and tracking of regulatory CMC and medical device activities. Your expertise will be crucial in ensuring adherence to relevant regulatory requirements and collaborating with internal and external partners.", "ul": [{"li": "Develop and execute global regulatory CMC and device strategies and submissions, including CMC dossiers to support clinical trial applications and marketing applications"}, {"li": "Collaborate with internal Technical Operations colleagues and external organizations to develop submission content plans and timelines and support the timely execution of regulatory submissions that require CMC content, responses to questions, audits, and inspections"}, {"li": "Manage the preparation, drafting, review, risk analysis, and mitigation planning of CMC submissions, e.g., Module 3 IND, IMPD, amendments, and annual reports"}, {"li": "Develop and maintain internal cross-functional relationships to support the development and execution of CMC regulatory submissions"}, {"li": "Responsible for the regulatory assessment of change controls, maintenance of regulatory files, and tracking databases related to CMC submissions"}, {"li": "Lead/support the development of processes, SOPs, and other controlled documents, including for Regulatory Affairs activities"}], "h2": "Your Profile", "p": "We are looking for a highly skilled and experienced Senior Manager Regulatory Affairs CMC to join our team. The ideal candidate will have a strong background in CMC Regulatory Affairs and experience working with regulatory authorities such as the FDA and EMA.", "ul": [{"li": "Minimum of first degree in life sciences (or equivalent); advanced degree (e.g., PhD or Masters) preferred"}, {"li": "Experience in CMC Regulatory Affairs within the pharmaceutical or biotechnology industry"}, {"li": "Experience and knowledge in preparation of CMC sections of INDs, CTAs, and marketing applications is required"}, {"li": "Working knowledge of FDA, EMA, ICH, and cGMP CMC regulatory guidance and regulations"}, {"li": "Experience working with recombinant proteins is highly desirable"}, {"li": "Experience interactions with health authorities such as scientific advice or agency meetings, including with FDA, is desirable"}], "h2": "Why Join Us", "p": "At MoonLake Immunotherapeutics, we offer a dynamic and innovative work environment that allows our employees to grow and develop their skills. We are committed to making a positive impact on the lives of patients and are looking for talented individuals to join our team.", "ul": [{"li": "Learning Environment: An opportunity to learn and grow alongside experienced professionals in a supportive and innovative biotech environment"}, {"li": "Impactful Work: Contribute to ground-breaking projects that have the potential to transform global healthcare"}, {"li": "Flexibility and Balance: Work remotely/hybrid, enjoying a healthy work-life balance while making meaningful contributions to our team"}, {"li": "Career Growth: A clear path for career progression, with the chance to take on more responsibilities as you develop your skills"}]}