Your responsibilities include, but are not limited to:

• Participation as a member of CMC team in interdisciplinary project teams; partner with Quality, Research & Development, Manufacturing, Clinical and Regulatory teams;

• Providing regulatory guidance to analytical project teams on all aspects of technical development and production;
• Active participation in defining CMC regulatory strategy. Materials preparation for regulatory decision making, balancing risks and benefits;  
• Authoring and/or reviewing of high-quality CMC documentation for Health Authority submissions (i.e., CMC content of Module 3 sections for IMPDs/INDs, MAAs/BLAs, briefing books);
• Preparation of and/or supervision over responses to CMC-related questions from Health Authorities to ensure regulatory approvals. Participation and preparation of materials for meetings with Health Authorities (e.g. EMA, FDA and local ones) depending on the scope of a meeting;
• Coordination over the format of the quality documentation from third parties (external stakeholders) and assurance of documentation consistency;
• Filing and archiving regulatory documentation, including correct formatting according to global requirements.
• Preparation and verification of NCBiR grants;
• Assistance and participation in unit inspections (CMC scope of topics);
• Participant and/or coordinator of cross-functional matrix teams for preparation of regulatory submissions;
• Co-responsible for successful implementation of strategic CMC plans. Ability to achieve timely submissions and to adhere to regulatory requirements;
• Interact with external contacts from license partners, service providers and CMOs.

If you have:

• Over 8 years of industry experience with focus on biologics/monoclonal antibodies (ideally biosimilars), including both development and commercial pharmaceutical products;
• MSc or PhD in biotechnology, biochemistry, biology or equivalent;
• Expertise in CMC topics, including aspects such as cell line development, process development, analytical methods, comparability studies and/or similarity assessments as well as in biological medical products registration process US/EU/MHRA;
• Expertise in guidelines with focus on EU and US;
• Practical experience in registration processes and handling post-approval changes (e.g.: preparation of CMC content of Module 3 sections for IMPDs/INDs, MAAs/BLAs, briefing books, post-approval changes; and related interactions with Health Authorities);
• Excellent planning, communication, documentation and organizational skills with hands-on mentality;
• Ability to work successfully in a matrix organization in cross-functional teams;
• Ability to coordinate task oriented groups;
• Orientation towards collaboration and aligned decision-making;
• Technical writing skills (pharmacy/biotechnology);
• Professional proficiency in both written and spoken English, Polish language is an advantage.

What we offer:

• Competitive salary; 
• Private healthcare;
• Life insurance;
• Pension plan above national standards;
• Additional free day;
• and more..