Regulatory Affairs CMC Specialist

We are seeking an experienced Regulatory Affairs professional with strong CMC expertise to support global regulatory activities across a diverse portfolio. This role is ideal for someone with advanced knowledge of regulatory requirements and experience across multiple modalities, particularly peptides and proteins.

You will play a key role in shaping regulatory strategy, leading submissions, and engaging with global health authorities to ensure successful product development and lifecycle management.

Key Responsibilities

Regulatory Strategy & Submissions

• Lead submission planning by applying regulatory intelligence and developing effective global regulatory strategies
• Prepare, compile, and maintain high-quality regulatory dossiers
• Manage and execute submissions to health authorities worldwide, including:
• MAA, NDA, BLA
• CTA/IND
• Device Files, CE marking, NBOp
• Site Master Files
...

Ready to Apply?

Submit your application today and join our talented team at G&L Scientific.