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- Tasks: Provide expert CMC regulatory advice and support drug development processes.
- Company: Leading pharmaceutical consultancy focused on quality and regulatory support.
- Benefits: Competitive salary, remote work options, and relocation support available.
- Why this job: Join a dynamic team and make a real impact in drug development.
- Qualifications: PhD or Master’s in relevant field with 5+ years in CMC regulatory affairs.
- Other info: Collaborative environment with opportunities for travel and professional growth.
The predicted salary is between 36000 - 60000 £ per year.
Location: Munich, Germany (1–2 days remote working)
Position: Permanent opportunity
Rate: Competitive market salary
CK Group are recruiting on behalf of a science-led pharmaceutical and biotechnology consultancy providing expert CMC, quality, and regulatory support across drug development.
The Role: This is a client-facing CMC Regulatory Consultant position, acting as a technical and quality expert across a broad range of drug substances and drug products. The role covers CMC and quality topics from pre-clinical development through to approved commercial products, working closely with internal experts, clients, and external partners.
Key Responsibilities:
- Provide scientific and regulatory advice on CMC and quality aspects of drug development.
- Ensure CMC work packages and documentation are phase-appropriate and aligned with regulatory expectations.
- Prepare quality sections for regulatory submissions, including IND, IMPD, BLA, NDA, and MAA.
- Perform gap analyses on client CMC packages and develop mitigation strategies.
- Support due diligence activities.
- Prepare briefing packages and participate in regulatory agency meetings, including scientific advice and milestone meetings.
- Manage operational and strategic interactions with CDMOs.
- Coordinate filing activities across cross-functional teams and external contributors.
- Maintain awareness of evolving regulatory guidance and requirements.
- Support quality and CMC readiness for regulatory submissions and inspections.
- Contribute to structured review, follow-up, and coordination of quality documentation.
- Liaise with internal teams and external partners to ensure compliance with regulatory expectations.
Your Background:
- PhD or Master’s degree in Pharmacy, Chemistry, Biopharmaceuticals, Biochemistry, Biology, or a related discipline.
- At least five years’ experience in CMC development or CMC regulatory affairs within a scientific or technical environment.
- Hands-on experience with regulatory filings such as IND, IMPD, BLA, NDA, or MAA.
- Strong understanding of CMC and regulatory requirements across all development stages.
- Confident communicator in English; German language skills are an advantage.
- Comfortable working in a collaborative, client-focused consulting environment.
- Willingness to travel moderately for client, agency, or CMO meeting.
Apply: Please send your CV and cover letter in English. It is essential that applicants hold entitlement to work in Germany, or make it clear if a visa is required. Relocation support is provided. Please quote job reference in all correspondence.
CMC Regulatory Consultant - Permanent in München employer: CK Group- Science, Clinical and Technical
Contact Detail:
CK Group- Science, Clinical and Technical Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land CMC Regulatory Consultant - Permanent in München
✨Tip Number 1
Network like a pro! Reach out to your connections in the pharmaceutical and biotechnology sectors. Attend industry events or webinars to meet potential employers and get your name out there.
✨Tip Number 2
Prepare for interviews by brushing up on your CMC knowledge and regulatory affairs. Be ready to discuss your hands-on experience with regulatory filings and how you can contribute to the team.
✨Tip Number 3
Showcase your communication skills! Practice explaining complex CMC concepts in simple terms, as you'll need to liaise with clients and internal teams effectively.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive about their job search.
We think you need these skills to ace CMC Regulatory Consultant - Permanent in München
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the CMC Regulatory Consultant role. Highlight your relevant experience in CMC development and regulatory affairs, especially any hands-on experience with filings like IND or NDA. We want to see how your background aligns with what we're looking for!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about this role and how your skills make you a perfect fit. Don’t forget to mention your willingness to travel and your experience in a client-focused environment – we love that!
Showcase Your Communication Skills: As a CMC Regulatory Consultant, strong communication is key. In your application, demonstrate your ability to convey complex information clearly. Whether it's through your CV or cover letter, let us see your confident communication style, especially in English!
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you don’t miss out on any important updates. Plus, it shows you’re keen on joining our team at StudySmarter!
How to prepare for a job interview at CK Group- Science, Clinical and Technical
✨Know Your CMC Inside Out
Make sure you brush up on your knowledge of CMC and regulatory affairs. Be prepared to discuss specific examples from your experience, especially with regulatory filings like IND, IMPD, BLA, NDA, or MAA. This will show that you’re not just familiar with the terms but can apply them in real-world scenarios.
✨Showcase Your Client-Facing Skills
Since this role is client-facing, think about times when you've successfully communicated complex information to clients or stakeholders. Prepare anecdotes that highlight your ability to build relationships and provide clear, actionable advice. This will demonstrate your fit for a consulting environment.
✨Prepare for Technical Questions
Expect technical questions related to CMC and quality aspects of drug development. Review recent regulatory changes and be ready to discuss how they might impact CMC work packages. This shows that you’re proactive and keep up with industry trends, which is crucial for this role.
✨Ask Insightful Questions
At the end of the interview, have a few thoughtful questions ready about the company’s approach to CMC challenges or their expectations for the role. This not only shows your interest but also gives you a chance to assess if the company aligns with your career goals.