Regulatory CMC Specialist

Regulatory CMC Manager / Senior Manager

Location : Munich (On-site, full-time, permanent)

Overview

We are seeking a Regulatory CMC professional with hands‑on experience authoring and leading CMC regulatory submissions across early and late stage development. This role is central in ensuring CMC strategy, documentation, and communication align with global regulatory expectations, supporting successful approvals and lifecycle management.

Key Responsibilities

• Lead and author CMC sections for regulatory submissions including IND, IMPD, MAA, NDA, and BLA, ensuring technical accuracy and regulatory compliance.
• Develop and implement RegCMC strategies across drug substance and drug product development programs.
• Coordinate with internal Technical Development, Quality, Manufacturing, and Project teams to ensure alignment of CMC data, timelines, and documentation.
• Represent CMC in scientific advice and regulatory agency interactions, contributing to strategy and preparation of briefing packages.
• Prepare and maintain CMC components of briefing books, regulatory responses, and variation filings.
• Provide regulatory guidance on changes, stability, specifications, analytical methods, comparability, and process validation approaches.
• Support lifecycle management activities and post‑approval CMC commitments.

Requirements

• Degree in Pharmaceutical Sciences, Chemistry, Biology, or related field; advanced degree preferred.
• Proven hands‑on RegCMC experience including direct authorship of CMC sections for IND / IMPD and at least one major global marketing application (MAA, NDA, or BLA).
• Experience participating in regulatory meetings / scientific advice with EU and / or US agencies.
• Solid understanding of ICH, EMA, FDA guidance related to quality, development, and commercialization.
• Excellent written communication, documentation structure, and cross‑functional collaboration skills.
• Ability to work on‑site in Munich full‑time.
• Experience across small molecules, biologics, or advanced modalities.
• Familiarity with outsourced manufacturing models (CMOs / CDMOs).

What We Offer

• Permanent, on‑site role in a collaborative R&D environment.
• Opportunity to directly shape regulatory strategy from development to approval.
• Competitive compensation and benefits package.

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