Regulatory CMC Manager/ Senior Manager
Gdańsk

Boost your career with us

Polpharma Biologics is a state-of-the-art biological R&D and manufacturing facility, one of the most modern in Europe. We have a fantastic, international team of experienced experts and dynamic young scientists with common goals and values. Biotechnology is our passion.

Together we develop medicines, offering a new hope to patients suffering from serious diseases. We create a passionate and friendly workplace environment. Join us!

Your role

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.

Your responsibilities

  • 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.

If you have

  • 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.

We offer

• Private healthcare;
• Life insurance;
• Pension plan above national standards;
• Relocation package;
• Additional free day;
• and more…

Join our Team!

Why you should work with us

Contact us
[email protected]