Regulatory CMC Consultant – Permanent Position (Germany) Are you an experienced CMC professional ready to influence innovative drug development programs across the globe? This is an opportunity to step into a strategic consultancy role supporting cross-functional development teams working on small molecules, biologics, ATMPs, oligonucleotides, and advanced formulations from early research through to marketing authorisation. We are a specialised, science-driven regulatory consulting group with an exceptional track record delivering high-value CMC strategy, regulatory documentation, and development support for international biotech and pharma partners. You will join a collaborative, expert team operating within a matrix environment, providing guidance throughout the full lifecycle—from preclinical development to post-approval. What We Offer A supportive, intellectually stimulating environment within a specialised high-performance team Exposure to cutting-edge drug development programs across multiple modalities and geographies Outstanding compensation, including a highly competitive salary and an exceptional performance-driven bonus structure Opportunities for continuous learning, professional growth, and scientific impact A hybrid setup with moderate travel to clients, agencies, or manufacturing partners What You Will Do Advise clients on CMC strategy, quality requirements, and regulatory expectations across global markets Ensure CMC packages and documentation are development-phase appropriate and submission-ready Prepare quality sections for IND/IMPD, NDA/BLA/MAA submissions Conduct gap analyses of CMC data and develop mitigation strategies Support due diligence activities on technical CMC elements Prepare and deliver scientific advice briefing packages and participate in agency interactions Oversee operational and strategic CMC activities with CDMOs Coordinate cross-functional inputs for regulatory filings Stay current with evolving global CMC and regulatory guidance What We’re Looking For (Must-Haves) PhD or Master’s degree in Pharmacy, Biopharmaceuticals, Chemistry, Biochemistry, Biology, or related sciences 5+ years of hands‑on CMC development or CMC Regulatory Affairs experience Direct experience preparing and managing regulatory submissions (IND/IMPD, NDA/BLA, MAA) Deep understanding of CMC requirements across development stages, including preclinical, Phase I–III, and commercial Expert knowledge across diverse modalities (e.g., biologics, peptides, small molecules, oligos, sterile products, nanoparticle systems) Excellent communication and negotiation skills in English Proven ability to work in cross‑functional, client‑facing environments Strong analytical skills with the ability to identify risks and propose solutions Proficiency with standard MS Office tools Nice to Have Experience collaborating with CDMOs Prior consultancy or multi‑project environment experience Seniority level Mid‑Senior level Employment type Full‑time Job function Research #J-18808-Ljbffr