Regulatory affairs & CMC Specialist

Regulatory Affairs Specialist – CMC

Location: Germany (Hybrid / On-Site)

Employment Type: Permanent

Overview

We are seeking an experienced Regulatory Affairs Specialist with strong CMC expertise to join our growing team. This role is ideal for someone with a rigorous scientific background (Master’s or PhD required) and hands‑on experience supporting regulatory submissions across early and late‑stage development.

Key Responsibilities

• Prepare, review and maintain CMC documentation for global regulatory submissions (IND, IMPD, CTA, MAA, NDA, BLA).
• Support regulatory strategy for CMC topics across drug substance and drug product.
• Contribute to scientific advice meetings, briefing books, and responses to health authority queries.
• Ensure alignment of CMC development activities with applicable guidelines (EMA, FDA, ICH).
• Collaborate closely with Quality, Process Development, Analytical, and Clinical teams to ensure regulatory compliance.
• Maintain oversight of CMC change controls and post‑approval variations.

Requirements

• Master’s or PhD in Life Sciences, Pharmacy, Chemistry, Biochemistry or related field (mandatory).
• 3–7+ years of experience in Regulatory Affairs with a CMC focus.
• Demonstrated experience authoring, reviewing, or contributing to CMC modules for global submissions.
• Strong understanding of drug development processes, GMP, and regulatory expectations.
• Excellent written and verbal communication skills.
• Ability to work cross‑functionally and manage multiple priorities.

What We Offer

• Opportunity to work on diverse development programs across multiple modalities.
• A collaborative, science‑driven environment with strong career development potential.
• Competitive compensation and benefits.

#J-18808-Ljbffr