Associate Director Regulatory Affairs CMC

Join our mission to close in on cancer.

The Team

As a member of our CMC (Regulatory Affairs) team, you will play an important role in managing, writing, preparation, and review of RA-CMC regulatory filings for submissions of Merus’ product candidates in compliance with the applicable regulatory and quality requirements. You will also provide biopharmaceutical CMC-content related regulatory advice to the rest of the CMC team.

The Role

As Regulatory Affairs CMC Officer, your main tasks and responsibilities are the following:

• Preparation and co-review of CMC sections of regulatory filings
• Managing Regulatory Affairs CMC-related projects of Merus’ product candidates both internally (with Merus colleagues) and externally (third parties)
• Ensuring that CMC regulatory filings are in compliance with internal procedures, regulatory guidelines, and according to GMP, GLP, and/or GDP, where applicable
• Provide regulatory advice on CMC technical and quality matters to the rest of the CMC team, such as manufacturing process development, specifications, in process controls, and change control management

Managing the communication and follow-up with Competent Authorities on CMC regulatory related feedback received.

Your Profile

We are looking for a Regulatory Affairs CMC Manager with the following knowledge and expertise:

• You hold a Master’s degree in a relevant biomedical field and have at least 3 years of relevant working experience within the (bio)pharmaceutical industry or other relevant regulatory experience
• You have a good understanding of Regulatory Affairs (EU/US/ROW)
• You have a good understanding of various quality systems such as GMP, GLP, and GDP
• You are a team player focused on results
• You have an analytical mindset and attention to detail
• You are known for your organization skills and drive to continuously improve your work
• You communicate well in English, both verbally and in writing

Why Merus?

We offer a once-in-a-lifetime opportunity to work with some of the best and brightest in the biotech industry. As part of Merus, you’ll experience a steep learning curve from your very first day in the job. And you’ll get to interact with a great international team of people who love what they do! To top it all, we offer a competitive salary, flexible working hours, an excellent pension scheme, a company bonus, and 30 days’ annual leave (based on a full-time position). Most importantly, you’ll have the chance to help us close in on cancer – everything you do matters at Merus.