Polpharma Biologics is a biopharmaceutical company with state-of-the-art facilities across Europe. Operating across international centers of excellence specialized in cell line development, product and process development, clinical manufacturing, commercial scale production and regulatory affairs, allows us to work and partner on our in-house biological pipeline (biosimilars and novel biologics) and at the same time provide top-quality contract development and manufacturing services to the industry.
- International work environment
- Attractive salary
- Cutting-edge technology equipment
- Conferences and trainings around the world
Our growing regulatory team will give you the opportunity to have a true impact on the success of your projects beyond what is possible in established large biotech companies. You will actively collaborate with cross-functional development teams and leadership representatives regarding strategical and operational topics from early development up to product registration and launch.
- Provide regulatory guidance to projects teams on all aspects of technical development and production.
- Ensure that CMC sections for IMPDs/INDs, MAAs/BLAs and briefing books are written on time and with high quality, in close collaboration with other members of the regulatory team.
- Respond to CMC-related questions from health authorities to ensure regulatory approvals.
- Prepare the technical development team and take part in CMC-related health authority meetings, identify risks and develop response strategies.
- Ensure document review and approval workflows are in place and maintained, actively monitor progress and find solutions in case of issues.
- Escalate CMC issues impacting submission timelines to the leadership team.
- File and archive regulatory documentation, including correct formatting according to global requirements.
- Coach/mentor junior regulatory affairs team members.
- Monitor changes in the regulatory landscape impacting quality aspects of biosimilar development.
- MSc/PhD in biotechnology, biochemistry, biology or equivalent.
- 3-5 years (Regulatory CMC Manager) or > 7 years (Regulatory CMC Senior Manager) of industry experience in regulatory CMC activities with focus on biologics/monoclonal antibodies, ideally biosimilars.
- Track record in the preparation of the CMC/quality sections of CTAs, INDs and ideally MAAs/BLAs.
- Practical experience in CMC development, including aspects such as cell line development, process development, analytical methods, comparability studies and similarity assessments.
- Knowledge of relevant legislation and international guidelines with focus on EU and US.
- Excellent planning, communication, documentation and organizational skills with hands-on mentality.
- Ability to work successfully in a matrix organisation in cross-functional teams.
- Fluent English (written and oral), Polish of advantage.
- Sport Card
- Development programs
- Private healtcare
- Relocation package
- Fruit day
- Integrations events
- Benefit platform
- and more
Aleksandra Bufnal
aleksandra.bufnal@PolpharmaBiologics.com