Join a leading organization in the pharmaceutical industry as a Regulatory Affairs Manager. You will play a key role in preparing and managing regulatory submission dossiers, ensuring timely registration of products in key markets. Collaborate with clients and internal teams, providing strategic input on formulation and development. Enjoy a challenging and responsible position in a dynamic and growing environment, with a competitive salary and benefits package. Read on to discover why this job might be perfect for you.

Over het bedrijf

QTC Recruitment

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Our client is a leading organization in the pharmaceutical industry, involved in various aspects such as product development, registration, production, and commercialization of pharmaceutical products, as well as offering pharmaceutical services. With a growing team of professionals, they are expanding to continue providing exceptional services to their clients. As part of this growth, they are currently seeking a Regulatory Affairs Manager.

This is how you will make the difference

As a Regulatory Affairs Manager, you will be responsible for preparing and managing regulatory submission dossiers for pharmaceutical products to secure registration in key markets, ensuring deadlines are met and collaborating with clients. You will coordinate variations according to guidelines and provide strategic input on formulation, process, and method development. Achieving milestones related to dossier goals is essential, as is maintaining communication with internal teams, stakeholders, and regulatory authorities. Additionally, you will draft reports for both internal and external use while actively participating in team discussions.

What you bring

You, as the ideal Regulatory Affairs Managerwill recognise yourself in the following:

Minimum 3 years of experience performing various regulatory affairs duties including writing CMC part within a pharmaceutical company;
Thorough knowledge of EU and national regulations/guidelines in the field of regulatory affairs;
Solid understanding of compiling, updating, and amending registration dossiers, as well as electronic submission processes;
Proficiency in Word, Excel, and (preferably) Adobe Acrobat;
Detail-oriented, with strong planning, organizational skills, and results-driven mindset

What's in it for you

What we offer:

a challenging and responsible position
dynamic and growing organisation
competitive salary and benefits package

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