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if you want to work:

in one of the most modern biotechnology
centres in Europe
 
in place where profesionals
from all over the world work
on the highest-quality equipoment
 
in the production
of biotechnological
drugs, which dive access
to effective therapy to
more patients
 
in a company that will dive you stable employment competetive remuneration attracive benefits and the opportunity to participate in training at home and abroad
 
Currently we’re looking for
CMC Regulatory Affairs Senior Specialist

Join “start-up” Biologics division with strong international and local team at site!

 

 
We are waiting just for you!


 
 

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
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