Regulatory Affairs Specialist – ATMP
il y a 1 semaine
QbD - Regulatory Affairs Specialist - ATMP in Belgium
Table of Contents
Join our QbD team where Regulatory Affairs services cover regulatory strategy, CTD registration dossier writing, eCTD compilation, and submission to competent authorities, extending to Vigilance. We provide support from concept to commercialization. Are you passionate about ensuring organizational compliance with regulations and laws related to ATMPs? Do you excel in guiding teams through intricate regulatory requirements in an efficient and practical manner? Then consider becoming part of our Regulatory Affairs Division.
What we expect from you as a Regulatory Affairs Specialist - ATMP:
- You ensure compliance with (inter)national regulations and international standards.
- You stay updated on evolving regulations in regions relevant to product development, manufacturing, registration, and distribution, advising on business impact.
- You align departmental operations with approved strategies, objectives, and budgets.
- You assist clients in obtaining and maintaining marketing authorizations for their products.
- You provide regulatory guidance to project teams for continuous compliance from early development to post-approval phases.
- You advise on regulatory and scientific requirements, collecting and evaluating scientific data.
- You contribute as a CMC writer for IMPD/IND and/or MAA/NDA/BLA submissions.
- You oversee document exchange and presentation to regulatory authorities.
- You prepare briefing packages for agency meetings and engage with relevant regulatory agencies.
- You conduct training on ATMP regulations and submission procedures.
Who are we looking for?
- You hold a master's degree in a scientific discipline with 2-3 years of experience in regulatory affairs, CMC writing, or non-clinical development in ATMPs.
- You possess in-depth understanding of ATMP regulations, GMP requirements, and technical standards applicable to ATMPs.
- You have expertise in preparing regulatory documentation for various stages of ATMP drug development.
- You are adept at early stage considerations and regulatory plan development.
- You have strong CMC writing skills to ensure regulatory compliance.
What does QbD Group offer you?
- An attractive salary package including monthly wage, car, fuel card, insurance, meal vouchers, etc.
- Opportunities for sustainable careers and meaningful connections.
- Work for an award-winning company with a focus on knowledge.
Our promise to you:
- We provide an environment for growth within the life sciences industry.
- We foster a joyful community where individuality is celebrated for collective growth.
- Experience the JPEG at QbD: Joy in Partnership, going the Extra mile to Get things done.
Interested? Send us your CV and motivation letter to join the QbD family
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