Regulatory Affairs 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

  • Providing regulatory guidance to projects teams on aspects of clinical and non-clinical development
  • Driving preparation of CTAs/INDs and MAAs/BLAs according to project timelines. Ensuring high quality of regulatory documentation in close collaboration with members of the regulatory team and external consultants. Coordinating handover of CTAs for local submissions. Maintaining IND including direct interactions with FDA program managers
  • Liaising with regulatory counterparts at CROs to align on requirements for clinical studies
  • Ensuring that questions from health authorities are answered on time
  • Leading the preparation and taking part in health authority meetings, identifying risks and developing response strategies
  • Ensuring document review and approval workflows are in place and maintained, actively monitoring progress and finding solutions in case of issues
  • Filing and archiving regulatory documentation, assuring correct formatting according to global requirements
  • Monitoring changes in regulatory guidelines, activities of competitor programs and updates in the labelling of originator products based on data base searches. Identifying regulatory trends impacting biosimilar development
  • Coaching/ mentoring junior regulatory affairs team members

If you have

  • MSc/PhD in pharmaceutical sciences, biotechnology, biology, biochemistry or equivalent.
  • > 7 years (Regulatory Affairs Senior Manager) of industry experience in regulatory affairs, ideally with focus on biosimilars.
  • Track record in the preparation of CTAs and INDs (and ideally MAAs/BLAs). Knowledge in procedural aspects of regulatory submissions for EMA and FDA.
  • Experience working together with CROs and external consultants in the review of clinical study protocols and reports, Investigator Brochures and Informed Consent Forms.
  • Practical experience in eCTD publishing and compilation of dossiers.
  • Excellent planning, communication, documentation and organizational skills with hands-on mentality
  • Ability to work successfully in a matrix organization in cross-functional teams
  • Knowledge of relevant legislation and international guidelines with focus on EU and US
  • 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]