Polpharma Biologics is part of the Polpharma Group, one of the largest pharmaceutical companies in Central and Eastern Europe. We focus on the development and production of biological medicines. Our international team consist of experiences experts and young scientists. We share common goal - to improve the quality of patients' ;ife with more availabe biological medicines of the hishest quality.
CMC Regulatory Affairs Senior Specialist
Location: Gdańsk
If you want to work:
- in one of the most modern biotechnology centres in Europe
- in a place where professionals from all over the world work on the highest-quality equipment
- in the production of biotechnological drugs, which give access to effective therapy to more patiens
- in a company that will give you stable employment, competitive renumerations, attractive benefits and the opportunity to participate in trainings at home and abroad
Currently we’re looking for
1
CMC Regulatory Affairs Senior Specialist
Support the CMC regulatory affairs function within Polpharma Biologics and prepare CMC documentation, fulfilling regulatory requirements of worldwide regulatory bodies, resulting in timely registration of Polpharma Biologics pipeline.
Join “start-up” Biologics division with strong international and local team at site!
We are waiting just for you!
What will you do?
- Ensure CMC documents for briefing books, CTAs, MAAs/BLAs, manufacturing amendments, responses to questions from regulatory authorities, and other documents as required, are written with high quality and delivered in a timely manner
- Guide cross-functional teams in development of high quality source documents as basis for regulatory documents, fulfilling state of the art regulatory requirements
- Provide regulatory assessment in change control teams and maintain product licenses per regulatory requirements
- Provide CMC/quality sections for submissions (including Module 3, analytical similarity assessments, briefing books, etc.)
- Prepare for CMC-related agency interactions
- Participate in development teams and collaborate with other functions, e.g. Technical Development, Production, and QA
- Involved into change control assessment and evaluation
- Escalate CMC issues and report progress to the regulatory, development and production leadership
- Ensure document review and approval workflows are in place and maintained, and actively monitors progress identifying issues for resolution.
- Assure correct document formatting according regulatory requirements as well as filing and archiving of documentation
What do we expect?
- MSc/PhD in biotechnology, biology or biochemistry (or equivalent)
- 3-5 years of industrial experience in regulatory activities with background on recombinant protein products/monoclonal antibodies, and ideally with biosimilars
- Ideally track record in international regulatory affairs and biotech products with practical experiences of registration procedures like CTA/IND submissions
- Practical experience with CMC development and handling European and US registration procedures
- Excellent planning, communication, documentation and organizational skills with hands-on mentality
- Ability to work successfully in a matrix organisation
- Fluent English, Polish of advantage
Poznaj
POLPHARMA S.A.
Zdrowe jutro zaczyna się od ludzi, którzy tworzą Polpharmę – od ich wiedzy, zaangażowania i pasji. Wspólnie dbamy o zdrowie innych i tworzymy środowisko, w którym każdy może być sobą. Rozwijamy się w zgodzie z własnymi ambicjami, niezależnie od obszaru, w jakim działamy. Razem z nami możesz realnie wpływać na zdrowie i dobrostan innych.