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Senior Manager
2 months ago
We are seeking a highly skilled Senior Manager - Regulatory Affairs CMC to join our Clinical Development team at MoonLake Immunotherapeutics. As a key member of our team, you will be responsible for the development, execution, and tracking of regulatory CMC and medical device activities.
Key Responsibilities- Develop and execute global regulatory CMC and device strategies and submissions, including CMC dossiers to support clinical trial applications and marketing applications.
- 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.
- Manage the preparation, drafting, review, risk analysis, and mitigation planning of CMC submissions, such as Module 3 IND, IMPD, amendments, and annual reports.
- Develop and maintain internal cross-functional relationships to support the development and execution of CMC regulatory submissions.
- Responsible for the regulatory assessment of change controls, maintenance of regulatory files, and tracking databases related to CMC submissions.
- Lead/support the development of processes, SOPs, and other controlled documents, including for Regulatory Affairs activities.
- Minimum of first degree in life sciences (or equivalent); advanced degree (e.g., PhD or Masters) preferred.
- Experience in CMC Regulatory Affairs within the pharmaceutical or biotechnology industry.
- Experience and knowledge in preparation of CMC sections of INDs, CTAs, and marketing applications is required.
- Working knowledge of FDA, EMA, ICH, and cGMP CMC regulatory guidance and regulations.
- Experience working with recombinant proteins is highly desirable.
- Experience interactions with health authorities such as scientific advice or agency meetings, including with FDA, is desirable.
- An opportunity to learn and grow alongside experienced professionals in a supportive and innovative biotech environment.
- Contribute to ground-breaking projects that have the potential to transform global healthcare.
- Work remotely/hybrid, enjoying a healthy work-life balance while making meaningful contributions to our team.
- A clear path for career progression, with the chance to take on more responsibilities as you develop your skills.
MoonLake Immunotherapeutics is a clinical-stage biopharmaceutical company unlocking the potential of sonelokimab, a novel investigational Nanobody for the treatment of the inflammatory disease, to revolutionize outcomes for patients.
We continue to make significant progress in our Global Clinical Development Programs. The company's focus is on inflammatory diseases with a major unmet need, including hidradenitis suppurativa and psoriatic arthritis – conditions affecting millions of people worldwide with a large need for improved treatment options. MoonLake was founded in 2021 and is headquartered in Zug, with hubs in Cambridge & Porto.
