Sr CMC Regulatory Affairs Project Consultant

Sr CMC Regulatory Affairs Project Consultant On behalf of our client, a biotech company focused on rare diseases, we are looking for a CMC Regulatory Affairs Specialist for a 50% contract position. *Please note that we can only consider EU/Schengen applications, or valid Swiss permit Responsibilities Act as the regulatory referent CMC expert, defining strategy from development through post-approval, including global submissions and Health Authority (HA) interactions, with a primary focus on pediatric programs and providing support to other projects as required. Lead the planning, authoring, and submission of high-quality CMC documentation (e.g., responses to Licensing Authorities questions and deficiency letters, Modules 2/3, DS/DP sections, briefing packages, clinical trial and marketing applications in US, EU, Japan, RoW). Provide regulatory guidance on CMC development (formulation and process development source documentation requirements), changes, deviations, and life‑cycle management, including risk assessment of manufacturing and control strategies. Prepare responses to HA questions/deficiency letters and support inspections for GMP/cGMP compliance. Collaborate cross‑functionally (CMC, Analytical Development, Quality, Nonclinical, Clinical, Clinical Supply, RA, QA) to ensure timely submissions, approvals, and compliance with the Quality System. Contribute to the development and continuous improvement of regulatory processes and standards. Maintain oversight of regulatory activities, track global requirements, and ensure timely implementation of updates. Represent CMC Regulatory in project teams and lead CMC‑focused correspondence and negotiations with HAs in alignment with the global regulatory lead. Requirements PhD or MSc‑degree in Pharmacy, Chemistry, Biochemistry, Biology, Biotechnology or comparable 10+ years’ experience in drug development, 7+ years’ experience in independently authoring of CMC sections of INDs, IMPDs, NDAs or MAAs and Briefing Documents for Agency advice, including definition of RA CMC strategies Extensive experience in pediatric drug development specifically in the preparation of HA interactions, CTA, NDA/MAA and related evaluation of formulation and process development strategy Knowledge of technical/regulatory requirements of small molecule development Strong knowledge of current Good Manufacturing Practices (GMP), drug development regulations and guidelines including ICH, FDA, and EMA guidelines Knowledge and experience with PMDA practices are a plus. Demonstrating proactive project planning and management skills and solution‑oriented approach; quick learner and able to prioritize effectively showing strong negotiation and influencing skills Skilled in establishing and managing effective relationships with CDMOs and other external partners. Excellent verbal and written, communication and presentation skills (English). Fluency in writing CMC sections in regulatory documents such as IMPDs, INDs, NDAs, MAAs. German language skills are a plus Strong team player and ability to work across functions Comfortable in a small company environment that is fast paced, challenging and where all leaders must take on a hands‑on approach to get results Ability to multi‑task and manage workload independently with high flexibility Positive and pro‑active attitude, driven by science and the vision to improve disease management and patient care Sound knowledge of Microsoft Office applications Seniority level Mid‑Senior level Employment type Contract Job function Quality Assurance Industries Pharmaceutical Manufacturing #J-18808-Ljbffr