Job description
Main tasks:
We are looking for a candidate for a part-time position of CMC regulatory (Chemistry, Manufacturing, Controls) specialist who will support the development, manufacturing and registration of one of our products, an oral solid form, in compliance with the regulatory requirements of FDA and ICH.
- Preparating, compiling and updating CMC information in regulatory submission documentation of the product in accordance with FDA guidelines and requirements,
- Monitoring and cooperating with the R&D and manufacturing teams in order to assure compliance of the drug development stages with set standards,
- Assessment of compliance of technological and analytical stages of drug development with FDA regulatory guidelines and requirements,
- Identification and risk management concerning drug quality,
- Participation in the qualification and assessment of manufacturers for materials and products,
- Monitoring changes in pharmaceutical law and international guidelines regarding registration documentation.
Must have:
- Bachelor’s or Master’s degree in pharmaceutical, chemical or related fields - obtained in: an EU country or the USA or Great Britain,
- At least 3 years of documented experience in drug development role related to creating and reviewing the CMC part of regulatory submission documentation (IND, NDA, ANDA),
- Experience in preparing regulatory submissions of medicinal products for the FDA 505(b)(2) registration pathway,
- Knowledge of FDA regulatory requirements and ICH, CPMP, FDA guidelines and pharmaceutical law concerning CMC,
- Knowledge and understanding of ICH requirements regarding CTD formatting,
- Knowledge of the principles of Good Manufacturing Practice,
- Knowledge of English at a level enabling free communication with foreign registration agencies, experts, manufacturers, use of literature and guidelines, preparation of the required registration documentation,
- Ability to work independently, to meet the deadlines and timely collect the required information from various sources,
- Strong computer skills (MS Office, Google Workspace etc.).
Nice to have:
- Experience in preparing and updating regulatory submissions of oral solid forms containing controlled substances,
- Experience in quality control of medicinal products containing controlled substances,
We offer:
- Participation in a cutting-edge project of the development of an innovative drug candidate in multinational environment,
- Engagement in various phases of clinical drug development,
- Work in a creative, friendly and stimulating atmosphere hand-in-hand with experts and enthusiasts in biomedical field,
- Part-time position,
- Remote work.
