Vacancy CMC RA Consultant – Tilburg
For a drug development organisation offering an innovative combination of drug development knowledge, clinical trial design, and management, we are looking for a CMC RA Consultant. You will be dedicated to providing feedback and regulatory leadership on the design, execution and coordination of CC activities. Currently, they have operations throughout Europe, in countries such as France, Germany and Ireland and facilities in the UK and US. Their mission is to play a vital role in the development of new products that allow disease prevention and treatment. They do this by creating an environment where you as a professional can develop yourself and apply your valued talents. This organisation nurtures a place where respect, pro activity, teamwork and patience are core values. Due to the growth of the company, they are now looking for a CMC RA Consultant who is excited to be the steady point of contact for two important clients, which are big pharmaceutical companies. The team exists of eight experienced professionals with each their own speciality which makes it able to ‘shop’ for knowledge within the team. The teamleader used to be a consultant herself and was voted in unison with the team to become the new head a couple of years ago.
As the new CMC RA Consultant you will be bringing something new to the team and that is drug substance and drug development experience. As the role has a focus on regulatory affairs it is important that you enjoy writing and maintaining dossiers which not necessarily means you need tons of RA experience, but it’s helpful if you enjoy writing and are an above average writer who likes building dossiers. Your workweek will basically look like this: you will add your scientific input to CMC plans, protocols, reports and documents for different regulatory affiliated goals. You will lead multiple development projects, support and/or guide Due Dilligence and strategise on how to achieve CMC-RA development milestones. With your expertise you are able to facilitate multiple multidisciplinary drug development teams at different clients and engage with different parties, both internally and externally. To really be successful you will stay up to date on developments and trends in the CMC RA domain and identify the opportunities that contribute to the strategic goals. As you are engaging with existing clients you know what is important, what their needs are and thus get in tune with business development opportunities for existing and new clients. As a consultant with quite a bit of experience and knowledge, you will also pass on your knowledge and coach professionals to develop themselves as well.
What we like to see in the ideal candidate:
- BSc or higher degree in the Life Sciences
- Three to five years experience in early to late stage CMC development
- One year experience in CMC-Regulatory Affairs or proven affinity with RA
- Deep knowledge of drug development processes
- Experience in drug substance / drug product process development / manufacturing and / or analytics
- Project management experience
- Personality traits like solution minded, organisational skills, teamplayer and networking skills
In return for your time and energy we offer:
- A mature and stable team of professionals who is ready to welcome you with open arms
- A drug development organisation / consultancy with top class clients throughout Europe
- A base salary with a midpoint of around €70,000.- gross per year
- Secondary benefits such as a fully covered pension, health insurance coverage and much more
- A continuation of your journey in CMC RA drug development and apply it broadly through the industry
If you are interested in this job, or in similar ones, please feel free to contact me directly.
Senior Associate | Clinical Research