Regulatory CMC Manager

Are you passionate about navigating the complex world of regulatory affairs for biosimilars and combination products? Do you thrive in a cross-functional, fast-paced environment where science meets strategic decision-making? If so, we have the perfect opportunity for you.

We are looking for an experienced Regulatory Affairs CMC Manager to lead the development and execution of regulatory strategies for drug products and drug-device combination products. You will play an instrumantal role in shaping and delivering high-quality regulatory submissions and supporting key health authority interactions for biosimilar, innovative, and CDMO programs.

You will be responsible for: 

• Define and drive EU/US CMC regulatory strategy for combination products in line with enterprise goals.
• Lead and/or support the preparation and review of regulatory documentation (Module 3, IMPDs/INDs, MAAs/BLAs, briefing books).
• Serve as regulatory liaison with Health Authorities and Notified Bodies (EMA, FDA, BSI, TÜV-SÜD, etc.).
• Guide and collaborate with cross-functional project teams on technical development, production, and compliance.
• Evaluate change requests and ensure regulatory compliance throughout the lifecycle.
• Participate in scientific advice meetings and respond to CMC and combination product queries.

Our expectations:

• MSc or PhD in Biotechnology, Biochemistry, Biology, Chemistry or a other life science degree.
• At least three years of regulatory CMC experience with either: biologics/monoclonal antibodies (biosimilars preferred), drug products, or medical devices (auto syringes, epipens, auto injectors).
• Familiarity with medical device/combination product regulations would an advandate. 
• Proven track record in preparing CMC sections of INDs, CTAs, and ideally MAAs/BLAs.
• Very good communication, project coordination, and organizational skills.
• Combination or strategic mindset paired with hands-on execution ability.
• Strong knowledge of EU and US regulatory landscapes.
• Collaborative spirit and ability to thrive in fast paced matrix organization.
• Fluent in English; proficiency in Polish is a plus.

What we offer:

• Employment at a company that is a leader in the Polish biotechnology sector, and contribute to life-changing medicines reaching patients globally.
• Collaboration with experts from the world’s leading biotechnology companies.
• Attractive benefits package, including:
  
  • Private healthcare.
  • Life insurance.
  • Employee Pension Program (EPP).
  • Annual and occasional bonuses.
  • Financial support for skills development.
  • Lunch card.
  • One additional day off per year (Polpharma Day).
• And much more...