Regulatory CMC Manager (f/m)
Gdańsk, PL
Join Rezon Bio, where biotech experts create biologics that improve lives worldwide - not by following the old rules, but by finding better, more reasonable ways to do things.
Built on the excellence of Polpharma Biologics, Rezon Bio is evolving into a Contract Development and Manufacturing Organization (CDMO) with a clear reason: to challenge the status quo and raise the bar in biotech.
With state-of-the-art centers in Gdańsk and Warsaw-Duchnice, we offer career opportunities across science, technology, and business for those who want their work to truly resonate.
Work alongside 1,300 professionals who combine global ambitions with local roots – driven by science, purpose, innovation, and respect for diversity.
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...
We fuel your professional growth and back it with a comprehensive benefits package. Our advanced facilities support both commercial-scale production and cutting-edge R&D, making us one of the most modern biotech organizations in Europe.
Here your ideas resonate and drive meaningful change. With continuous learning opportunities, many experts have already found their reason to return or relocate to Poland and grow their careers with us.
Does this resonate with you?
Learn more at RezonBio.com/careers and on LinkedIn