CMC Regulatory Affairs Senior Specialist
Place of work: Gdańsk
Job Purpose:
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.
Responsibilities:
- 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
Requirements/Qualifications:
- 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.