Regulatory CMC Writer
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 ARE YOUR RESPONSIBILITIES?
- 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.
WHAT DO YOU HAVE TO OFFER?
- 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 (e.g., manufacturing, analytical, quality assurance)
- Flexibility in dealing with change in priority and diversity.
- Strong critical and logical thinking.
- Able and willing to work in a fast-paced environment while handling multiple priorities.
WHAT DOES QBD OFFER YOU?
QbD is a healthy company with a strong growth and international ambitions. In addition to a very attractive salary package, we can offer you the following advantages:
- Our CEO, Bart Van Acker, became Flemish Young Entrepreneur of 2019, which means that you’ll be part of a vibrant, entrepreneurial organization.
- A company with a clear strategy and ambition.
- We've got your back! Our HR Business Partners follow you closely, giving you the opportunity to shape your career.
- Thanks to our flat organization, we have short communication lines and you can always come to us.
- Standing still means going backwards. With our extensive training package and our periodic knowledge-sharing moments, we offer you many opportunities to continuously learn, to expand or specialize your knowledge and skills and to gain new expertise.
- Get to know your colleagues outside the work environment! Teambuilding and fun activities are planned on a monthly basis. A comedy night or quiz night? Nothing is too crazy for us!
- 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!