Regulatory Affairs Specialist – ATMP

Regulatory Affairs Specialist – ATMP

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At QbD our RA Services go from regulatory strategy, clinical, CTD registration dossier writing, eCTD compilation and submission to competent authorities to Vigilance. We support from idea to commercialization. Do you want to ensure the organization’s compliance with the regulations and laws regarding ATMP’s? Do you want to guide them through complex regulatory requirements and guidelines? This all in an efficient and pragmatic way? Then apply now!

What are your responsibilities?

  • You guarantee that the regulatory requirements regarding (inter)national regulation and international standards are met.
  • You keep track of the ever-changing regulation in all the regions in which a company wishes to develop, manufacture, register and distribute its products and evaluate the impact on the business.
  • You align the operation of the departments with the realization of approved strategy, objectives and budget.
  • You advice the clients to obtain and maintain a marketing authorization for their products.
  • You provide regulatory advice to project teams to ensure continued regulatory compliance from the early development phase till the registration of the medicinal product and post approval changes  on non-clinical and quality related aspects of drug development and manufacturing in collaboration clinical experts.
  • You advise on the regulatory and scientific restraints and requirements, while collecting and evaluating scientific data.
  • As CMC writer, you generate the quality related sections of the IMPD/IND and/or MAA/NDA/BLA.  
  • Ensure that the content of non-clinical documents is appropriate, meets regulatory expectations and enables approval of regulatory submissions
  • You supervise the exchange and presentation of the registration documents to Notify Body or competent authority.
  • Prepare briefing packages for agency meetings (e.g. scientific advice, oral explanation, EoP2) and conduct such meetings together with the client
  • You work with supra-national/international, national, and local regulatory agencies (e.g. FAGG and EMA or FDA).
  • You train people on ATMP regulation and all its related aspects such as submission procedures.
 
Who are we looking for?

  • You hold a master’s degree in a scientific discipline (e.g. Pharmaceutical Sciences, Biotechnology, Biomedical Sciences, Biomedical Engineering, Biochemical Engineering…) with 2-3 years of experience in regulatory affairs and/or CMC writing and/or non-clinical development activities related to ATMPs
  • You have a good understanding and interpretation of the regulation for ATMP (Regulation (EC) No 1394/2007) and ATMP Classification (Regulation (EC) No 1394/2007 and Part IV of Annex I to Directive 2001/83/EC),), GMP requirements for Advanced Therapy Medicinal Products (Eudralex GMP part IV) and the technical standard applicable to ATMP (Guideline on the minimum quality and non-clinical data for certification of ATMPs)
  • You have experience in the preparation of regulatory documentation related to CTA, MAA, IND, BLA/NDA, more specific with regulatory CMC writing and knowledge of in non-clinical and regulatory requirements for all stages of ATMP drug development from pre-clinical to Phase III or commercial. You have knowledge of the relevant national and international legislation, procedural regulations and technical regulations.
  • As a consultant you feel comfortable taking care of the early stage considerations and the development of regulatory plans.
  • You like to work in cross-functional teams and have good people management skills.
  • You have an eye for detail and excellent writing and communication skills (English, Dutch, and/or French).
  • You are a skilled CMC writer, developing compliant Module 3 with appropriate level of detail to ensure that the content of CMC work-packages and documentation are phase appropriate, meet regulatory expectations and enable approval of regulatory submissions
  • You are result oriented, motivated and good at coordinating multiple projects and following up with internal/external stakeholders.
  • You like to communicate with other stakeholders and clients. You like to give training or be able to speak in front of professionals in de medical field.
  • And finally, if the words accurate, driven, flexible and organized cover your personality, you are the perfect Regulatory affairs specialist.

What does QbD offer you?
The QbD Group is a healthy and international company with strong growth ambitions (organic and inorganic). In addition to a competitive salary package, we can offer you the following advantages:

  • A company with a clear strategy and ambition.
  • You will work in a very dynamic organization (we don’t have speed limits) where we expect you to put your own stamp, have impact!
  • You are in a flat organization which means short communication lines, easy decision making and well… you won’t be shielded from hard work, ambition and some healthy pressure.
  • We've got your back! Our HR Business Partners follow you closely, giving you the opportunity to shape your career.
  • 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.
  • You’ll work in an award winning company:
    • Our CEO, Bart Van Acker, became Flemish Young Entrepreneur of the year 2019, which means that you’ll be part of a vibrant, entrepreneurial organization.
    • We were elected as Best Managed Company by Deloitte in 2020 & 2021
    • We hold the Baanbrekende Werkgever 2022 certificate (Pioneering Employer) 
    • Nominated as Trends Gazelle 2022 – Large Companies
  • Working in a value driven and data driven company where a people centric approach and business go hand in hand
  • We can only put the best of ourselves in our daily work when you also have some fun in the meantime and can build sustainable relationships with your colleagues and partners. We take care of JOY: Trans Alpes Nice Genève with our cycling team, triathlons, (trail) runs, parties and after works, our legendary annual weekend, charity events, … Get to know your colleagues outside the work environment!
  • In short… We go and 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!

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