CMC- Senior product developer

CMC Consultant

Looking for consultants ranging from a minimum if 5 years to 15+ years experience in CMC.

The CMC Consultant acts as a subject matter expert across drug substance and drug product development, covering a broad range of modalities (small molecules, oligonucleotides, biologics) and dosage forms (oral, sterile, nanoparticle formulations). This role supports projects from pre-clinical development through to commercial approval, ensuring CMC strategy, documentation and execution align with global regulatory expectations.

Tasks & Responsibilities

• Provide expert guidance on quality and CMC regulatory aspects of drug development, collaborating closely with cross-functional stakeholders.
• Ensure CMC work-packages and documentation are phase-appropriate, regulatory compliant and supportive of global submissions.
• Prepare CMC sections of IND / IMPD and BLA / NDA / MAA submissions.
• Perform CMC gap analyses, identify critical development risks, and define mitigation strategies.
• Support due diligence assessments as required.
• Prepare briefing packages for regulatory agency interactions (e.g., Scientific Advice, EoP2) and participate in agency meetings alongside project teams.
• Lead operational and strategic interactions with CDMOs.
• Coordinate regulatory filing activities with internal and external contributors.
• Maintain up-to-date understanding of evolving regulatory guidance and expectations.

Requirements

• Ph.D. or Master’s degree in Pharmacy, Chemistry, Biopharmaceuticals, Biochemistry, Biology, or related field.
• Minimum 5 years in CMC development and / or CMC Regulatory Affairs.
• Hands‑on experience with global regulatory filings (IND / IMPD, BLA / NDA / MAA).
• Strong communication, stakeholder management and negotiation skills in English.
• (Additional language skills are a plus.)
• Familiarity with CMC expectations across pre‑clinical to late‑stage or commercial development.
• Team‑oriented with strong interpersonal skills.
• Proficient in MS Office.
• Willingness to travel occasionally for client, partner, or agency meetings.

What’s Offered

• Collaborative and professional working environment alongside experienced industry experts.
• Competitive salary package with performance‑based bonus structure.
• Opportunities to work across diverse therapeutic areas and modalities, developing strategic and scientific depth.

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