CMC Regulatory Affairs Associate

CMC Regulatory Affairs Associate

Arbetsbeskrivning

Hays Life Science / CMC Regulatory Affairs Associate / 12-month / AstraZeneca, Södertälje

Hays Life Science is now looking for a CMC Regulatory Affairs Associate for a 12-month consultant assignment at our client AstraZeneca.



About AstraZeneca

CMC Regulatory Affairs is a global function that manages all Chemistry, Manufacturing and Controls (CMC) regulatory activities across AstraZeneca's global supply chain. We are looking for a CMC Regulatory Affairs Associate to join one of our CMC team focused on biologics products.



We are curious, creative, and open to new ideas and ways of working. Above all, we are passionate about science and driven to always put patients first. Join us and be part of an extraordinary place to work; an environment that energises and empowers each of us to support compliant product supply through partnership with other AZ teams.



The role

As a CMC Regulatory Affairs Associate, you will generate CMC documentation to support lifecycle submissions and keep business wide electronic systems up to date to maintain regulatory status.
You will work with colleagues and other functions within AstraZeneca to obtain information that supports the generation of regulatory CMC documentation.



Minimum Requirements - Education and Experience

* Degree in Chemistry or Pharmacy or Chemical Engineering, or equivalent experience
* Fluently spoken and written English and Swedish
* Experience in Pharmaceutical Production or Quality Assurance or Quality Control or Product Maintenance or Regulatory Affairs



Skills and Capabilities

* Experience of and interest in using Document Management systems
* Attention to detail, highly organised, able to plan and control own workload effectively and manage expectation of others
* Ability to work with short and / or changing timelines
* Able to work collaboratively with customers and colleagues to achieve optimum outcomes
* High level understanding of GMP and working in a regulated environment
* High level understanding of CMC Regulatory

* Excellent written and verbal communication skills

* IT software skills



What you need to do now

If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.

If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion about your career.

Kontaktpersoner på detta företaget

Rekryteringskonsult Nathalie Johansson
0858804337
Christin Rach

Konsult Andreas Stenlund
08 588 043 59
Konsult David Albenius
08 588 043 88
Researcher Carolina Osterman
0858804308 0704506006
Researcher Carolina Osterman
08-588 043 08 070-450 60 06
Rekryteringskonsult Mari Jehrlander
08-588 043 67
Rekryteringskonsult Ulrika Lind
0858804306 0704506004
Researcher Carolina Osterman

Sammanfattning

  • Arbetsplats: Hays AB
  • 1 plats
  • 6 månader eller längre
  • Heltid
  • Fast månads- vecko- eller timlön
  • Publicerat: 24 oktober 2023
  • Ansök senast: 3 november 2023

Besöksadress

STUREPLAN 4C
STOCKHOLM

Postadress

STUREPLAN 4C
STOCKHOLM, 11446

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