✨ The Role in One Sentence

MoonLake is seeking a Senior Specialist in Regulatory Affairs CMC to support the development and tracking of high-quality regulatory CMC and device documentation.

📋 What You'll Likely Do

• 40%: Prepare, edit, and finalize regulatory CMC documents for regulatory submissions.

• 30%: Collaborate with internal and external organizations to support timely execution of regulatory submissions.

• 30%: Support the tracking and maintenance of regulatory filings and databases related to CMC submissions.

🧑‍💻 Profiles Doing This Job

• High Priority: Minimum 3 years experience in CMC Regulatory Affairs.

• High Priority: Experience in preparation of CMC sections for INDs, CTAs, and marketing applications.

• High Priority: Working knowledge of FDA, EMA, ICH and cGMP CMC regulatory guidance and regulations.

📈 How This Role Will Look on Your CV

• Contributed to regulatory submissions for pharmaceutical products.