Regulatory CMC Writer

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Do you have a passion for technical, scientific writing? Do the words “responsible, communicative & effective” fit you perfectly? Then don’t hesitate and apply for this position!

What do we expect from you as a Regulatory CMC writer?

• Support the coordination and preparation of timely CTD file for submissions.
• Authoring and review of CMC submission components and documentation in CTD to support regulatory submissions for mainly EU (IMPD and MAA) and US-FDA (IND, BLA or NDA) submissions
• Ensure completion of high-quality submissions, following regulatory guidelines and internal processes within timelines
• Obtain information from other departments regarding regulatory submissions or documentation to support CMC submissions
• Assess and communicate potential regulatory risks and propose mitigation strategies
• Understands, interprets and advise teams on regulations, guidelines, procedures and policies relating to manufacture and control of medicinal products, to expedite the submission, review and approval of applications.
• Identify, communicate and escalate potential CMC regulatory issues, as needed
• Help establish regulatory CMC submission processes and procedures.

Who are we looking for?

• Working knowledge of word processing, spreadsheet and electronic database management systems.
• Experience in the CMC requirements for small molecules and / or vaccines / biologics
• Experience in critically reviewing detailed scientific information to assess technical merits and suitability of scientific rationale to ensure information is presented clearly and conclusions are adequately supported by data.
• Good understanding of the drug development process (, manufacturing, analytical, quality assurance)
• A true QbD’er can be recognized by : Resilience : Your strong and positive attitude helps you overcome any challenge Hunger for knowledge : gaining & sharing knowledge on a daily basis A no-BS mentality : you are straightforward in a respectful way Innovative mind : You are constantly looking for new and better solutions Being (not too) serious : your job is serious, but you don’t take yourself too seriously.

What does QbD Group offer you?

An attractive and complete salary package :

• A monthly wage, car, fuel card, (super fast) bicycle, insurance package, meal vouchers, etc.

But most of all…

• We offer sustainable careers and meaningful connections
• We are a knowledge based company
• You’ll work for an award winning company : Best Managed Company (Deloitte award), Baanbrekende Werkgever, …

Our promise to you :

• As an ambitious and pioneering company, we want to offer you the best possible environment to thrive within the life sciences.
• Moreover, we aim to create a joyful community where you dare to be and can be yourself. Because the best way to grow is by growing together as unique individuals .
• In short … We stand for JPEG : Joy in Partnership, going for the Extra mile to Get things done!

Interested?

Send us your CV and motivation letter and who knows, we might welcome you soon in our QbD family!