RegCMC Consultant/ Specialist

vor 1 Woche

Munich, Deutschland S3 Science Recruitment Vollzeit

Regulatory CMC Consultant – Permanent Position (Germany)Join a high-impact consultancy shaping global drug developmentAre 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 OfferA supportive, intellectually stimulating environment within a specialised high-performance teamExposure to cutting-edge drug development programs across multiple modalities and geographiesOutstanding compensation, including a highly competitive salary and an exceptional performance-driven bonus structureOpportunities for continuous learning, professional growth, and scientific impactA hybrid setup with moderate travel to clients, agencies, or manufacturing partnersWhat You Will DoAdvise clients on CMC strategy, quality requirements, and regulatory expectations across global marketsEnsure CMC packages and documentation are development-phase appropriate and submission-readyPrepare quality sections for IND/IMPD, NDA/BLA/MAA submissionsConduct gap analyses of CMC data and develop mitigation strategiesSupport due diligence activities on technical CMC elementsPrepare and deliver scientific advice briefing packages and participate in agency interactionsOversee operational and strategic CMC activities with CDMOsCoordinate cross-functional inputs for regulatory filingsStay current with evolving global CMC and regulatory guidanceWhat We’re Looking For (Must-Haves)We want top talent, so excellence in the following is essential:PhD or Master’s degree in Pharmacy, Biopharmaceuticals, Chemistry, Biochemistry, Biology, or related sciences5+ years of hands-on CMC development or CMC Regulatory Affairs experienceDirect 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 commercialExpert knowledge across diverse modalities (e.g., biologics, peptides, small molecules, oligos, sterile products, nanoparticle systems)Excellent communication and negotiation skills in EnglishProven ability to work in cross-functional, client-facing environmentsStrong analytical skills with the ability to identify risks and propose solutionsProficiency with standard MS Office toolsNice to Have:German language skillsExperience collaborating with CDMOsPrior consultancy or multi-project environment experience

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