Regulatory CMC Consultant – Permanent Position (Germany)
Join a high-impact consultancy shaping global drug development
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)
We want top talent, so excellence in the following is essential:
* 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:
* German language skills
* Experience collaborating with CDMOs
* Prior consultancy or multi-project environment experience