Associate Director Regulatory Affairs CMC (36-40 hrs)

Associate Director Regulatory Affairs CMC (36-40 hrs)

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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, as well as providing 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 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 for details; 
  • 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. 

Apply now

    Our Hiring Process

    Stage 1:

    Internal Review

    This means that we’ve received your application and are in the process of reviewing it.

    Stage 2:

    Initial Call

    We’ll set up a 15-minute phone call with our Internal Recruiter to discuss the details of this job opportunity and your own expectations of the role, as well as Merus as a company.

    Stage 3:

    1st Interview Phase

    During the 1st interview phase, we’ll set up an interview with your potential future manager. We’ll be looking to understand more about your experience, how that fits the role, and what makes you tick.

    Stage 4:

    2nd Interview Phase

    If things are still looking good, we’ll set up several short interviews with team members, peers, Management Team members (where relevant) and HR to make sure we are a good cultural fit. We do our best to plan these interviews on the same day, although on rare occasions they’ll take place on multiple days.

    Stage 5:

    Job Offer

    After positive evaluation from both sides, you will receive our job offer. Once you’ve accepted it, we will draw up the necessary paperwork. You will receive your contract within 3-5 working days and your onboarding process will start!

    Stage 6:

    Welcome

    We’re more than happy to welcome you to join Merus in our pursuit to close in on cancer!

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