RegCMC Consultant / Specialist

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

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