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- Tasks: Lead regulatory activities for drug substances, focusing on antibody-drug conjugates.
- Company: Join a dynamic team in Basel, Switzerland, dedicated to innovative drug development.
- Benefits: Enjoy a hybrid work model with 4 days on-site and 1 day remote, plus competitive salary.
- Why this job: Be at the forefront of drug development, making a real impact in healthcare.
- Qualifications: Strong CMC expertise in R&D or process development, with hands-on ADC experience required.
- Other info: Collaborate with top industry professionals and contribute to best practices in regulatory operations.
The predicted salary is between 80000 - 120000 £ per year.
Regulatory Affairs CMC Manager (Drug Substance – ADC focus) – Basel, Switzerland
4 days on site / 1 day remote
Salary range: 105K–120K CHF
Responsibilities
- Lead Drug Substance (DS) CMC regulatory activities, focusing on antibody–drug conjugates (ADCs), chemical payloads, and bioconjugates.
- Author and review clinical regulatory submissions from scratch (IMPD/IND, CTD Modules 2 & 3).
- Develop and document development pathways to support pipeline progression from early clinical to late-stage.
- Provide regulatory review of source documents (method validation, batch records, comparability data, stability).
- Collaborate closely with CDMOs and external manufacturing partners, overseeing tech transfer and ensuring regulatory alignment.
- Engage in cross-functional discussions with R&D, MSAT, and QA to ensure a seamless flow of CMC information into regulatory submissions.
- Contribute to internal process improvements and establish best practices for regulatory operations.
Qualifications
- Strong CMC Drug Substance expertise gained in R&D, process development, or MSAT, with readiness to take on a regulatory-facing role.
- Hands-on experience with ADCs or related bioconjugate platforms.
- Solid understanding of ICH guidelines, EU/FDA expectations, and CMC dossier requirements.
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Regulatory Affairs CMC Manager, Drug Substance employer: Barrington James Limited
Contact Detail:
Barrington James Limited Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs CMC Manager, Drug Substance
✨Tip Number 1
Network with professionals in the regulatory affairs field, especially those who have experience with ADCs and bioconjugates. Attend industry conferences or webinars to connect with potential colleagues and learn about the latest trends and challenges in the sector.
✨Tip Number 2
Familiarise yourself with the specific regulatory frameworks and guidelines related to drug substances and ADCs. This knowledge will not only boost your confidence but also demonstrate your commitment and expertise during interviews.
✨Tip Number 3
Prepare to discuss your hands-on experience with ADCs or related platforms in detail. Be ready to share specific examples of how you've contributed to CMC activities, as this will showcase your practical knowledge and problem-solving skills.
✨Tip Number 4
Engage with our company’s online presence. Follow us on social media and participate in discussions to show your interest in StudySmarter. This can help you stand out and demonstrate your enthusiasm for joining our team.
We think you need these skills to ace Regulatory Affairs CMC Manager, Drug Substance
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities of a Regulatory Affairs CMC Manager, especially in relation to Drug Substance and ADCs. Tailor your application to highlight relevant experience.
Highlight Relevant Experience: In your CV and cover letter, emphasise your hands-on experience with ADCs or bioconjugate platforms. Mention specific projects where you've led CMC regulatory activities or authored clinical submissions.
Showcase Your Knowledge: Demonstrate your understanding of ICH guidelines, EU/FDA expectations, and CMC dossier requirements in your application. This will show that you are well-prepared for the role and can contribute effectively.
Craft a Compelling Cover Letter: Write a cover letter that not only outlines your qualifications but also expresses your enthusiasm for the position. Discuss how your background aligns with the company's goals and how you can contribute to their success.
How to prepare for a job interview at Barrington James Limited
✨Showcase Your CMC Expertise
Make sure to highlight your strong background in CMC Drug Substance, especially your experience with ADCs and bioconjugates. Be prepared to discuss specific projects where you led regulatory activities or contributed to submissions.
✨Familiarise Yourself with Regulatory Guidelines
Brush up on ICH guidelines and EU/FDA expectations before the interview. Demonstrating a solid understanding of these regulations will show that you're well-prepared for the role and can navigate the complexities of regulatory submissions.
✨Prepare for Cross-Functional Collaboration Questions
Expect questions about how you've worked with R&D, MSAT, and QA teams in the past. Be ready to provide examples of how you facilitated communication and ensured a seamless flow of information for regulatory submissions.
✨Discuss Process Improvements
Think of instances where you've contributed to internal process improvements or established best practices in regulatory operations. Sharing these experiences will demonstrate your proactive approach and commitment to enhancing efficiency.