Senior Manager Regulatory Affairs CMC

1 day ago

Cambridge, Cambridgeshire, United Kingdom MoonLake Immunotherapeutics Full time
Job Purpose

As a Senior Manager, Regulatory Affairs CMC, you will play a pivotal role in MoonLake Immunotherapeutics' Clinical Development team, responsible for the development, execution, and tracking of regulatory CMC and medical device activities.

  • 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.
  • 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.

Key Responsibilities:

  • Partner with Regulatory Affairs and cross-functional colleagues to understand the CMC regulatory landscape, including regulatory precedents, labeling differences, and other CMC-specific issues.
  • Adapt to changes that may impact MoonLake development programs.

Requirements:

  • Experience in CMC Regulatory Affairs within the pharmaceutical or biotechnology industry.
  • Working knowledge of FDA, EMA, ICH, and cGMP CMC regulatory guidance and regulations.
  • Experience interacting with health authorities, such as scientific advice or agency meetings, including with FDA, is desirable.
  • Ability to proactively identify risks and develop risk mitigation strategies.
  • Adaptable with the ability to generate creative solutions, identify different and novel ways to find solutions, and adapt to changing priorities and deadlines.
  • Highly collaborative, strong relationship-building skills with internal and external partners, with a high level of integrity.

What We Offer:

  • Learning Environment: An opportunity to learn and grow alongside experienced professionals in a supportive and innovative biotech environment.
  • Impactful Work: Contribute to groundbreaking projects that have the potential to transform global healthcare.
  • Flexibility and Balance: Work remotely/hybrid, enjoying a healthy work-life balance while making meaningful contributions to our team.
  • Career Growth: A clear path for career progression, with the chance to take on more responsibilities as you develop your skills.

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