CMC Regulatory Affairs Consultant

Do you want to be a driving force in a rapidly expanding environment, making a tangible difference in the process?

Our Client a global leading Consultancy firm is looking for a CMC Regulatory Affairs person

Tasks

• Provide clients with expert guidance on quality-related considerations throughout drug development, working closely with internal specialists across multiple disciplines to ensure aligned and robust recommendations.
• Oversee the development and review of CMC deliverables and supporting documentation, ensuring that all materials are appropriately tailored to the development stage, reflect current regulatory expectations, and effectively support successful submission outcomes.
• Lead the creation of quality-focused content for major regulatory applications, including MAA, BLA/NDA, as well as IMPD and IND dossiers, ensuring accuracy, clarity, and compliance.
• Conduct comprehensive evaluations of client-supplied CMC data and documentation, identify gaps or risks impacting regulatory readiness, and design practical, science‑driven strategies to address them.
• Contribute to due diligence activities, providing scientific and regulatory insights to support informed decision‑making processes.
• Prepare detailed briefing materials for interactions with regulatory authorities (e.g., scientific advice meetings, oral explanations, end‑of‑Phase meetings) and participate in these engagements alongside clients.
• Manage both the operational and strategic dimensions of collaboration with CDMOs, ensuring alignment, quality oversight, and timely execution of development and manufacturing activities.
• Coordinate all CMC-related submission activities across the internal team and external contributors, ensuring smooth communication, clear accountability, and adherence to timelines.
• Maintain up‑to‑date knowledge of evolving regulatory requirements, guidelines, and authority expectations, and ensure their consistent application across all assigned projects.

Profile

• Advanced academic qualification (Ph.D. or Master's degree) in Pharmacy, Chemistry, Biopharmaceuticals, Biochemistry, Biology, or a closely related scientific discipline.
• Minimum of five years' experience in a scientific or technical CMC development role or within CMC-focused regulatory affairs, encompassing hands-on involvement across development programs.
• Proven experience preparing and contributing to regulatory submissions, including IND/IMPD and BLA/NDA/MAA filings.
• Outstanding communication and negotiation skills in English; proficiency in German is considered an advantage.
• Comprehensive understanding of CMC and regulatory requirements across all product development stages, from pre‑clinical through Phase III and into commercialization.
• A highly motivated and collaborative team player with strong interpersonal capabilities and the ability to work effectively with cross‑functional stakeholders.
• Solid proficiency in Microsoft Office applications.
• Willingness to undertake moderate travel, including attendance at client meetings, regulatory agency interactions, and visits to CMOs/CDMOs.

Please contact me on or please call me on +49 30 726211428 for further information.