Regulatory CMC Associate consultant to AstraZeneca

Are you fluent in both Swedish and English, have a chemistry degree and experience in quality management in a pharmaceutical company or pharmacy, look here! Experis engineering are now looking for a consultant to a role as a Regulatory CMC Associate at AstraZeneca. Welcome with your application!

Placering: 
Södertälje
Bransch: 
Teknik, Naturvetenskap
Antal tjänster: 
1

AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines for some of the world's most serious diseases. But we're more than one of the world's leading pharmaceutical companies. At AstraZeneca, we're proud to have a unique workplace culture that inspires innovation and collaboration. Here, employees are empowered to express diverse perspectives - and are made to feel valued, energized and rewarded for their ideas and creativity.

Operations Regulatory is a global function that manages all Chemistry, Manufacturing and Controls (CMC) post-approval regulatory activities across the global supply chain.

We are now looking for a Regulatory CMC Associate.

This role is available as a temporary contract and will be based in Södertälje, Sweden.


The role

The Regulatory CMC Associate generates CMC documentation presented in the required format to the agreed timetable, for worldwide submissions. You will work with colleagues and other functions to obtain information that supports the generation of regulatory documentation.

You may also coordinate assembly of submission-ready documents to support lifecycle submissions.

You will keep business wide electronic systems up to date to be consistent with regulatory submissions and commitments.

You may also support externalisation projects and transfer of CMC documentation to external partners.

The role will be based in Södertälje and you will work in a team of 8-10 people.

Minimum Requirements - Education and Experience

  • Degree in Chemistry or Pharmacy or Chemical Engineering
  • Fluently spoken and written English and Swedish
  • Experience in Pharmaceutical Production or Quality Assurance or Quality Control or Product Maintenance or Regulatory Affairs
  • Experience in Post Approval Regulatory CMC including CMC documentation authoring is desirable

Skills and Capabilities

  • Able to work collaboratively with customers and colleagues to achieve optimum outcomes
  • Knowledge of information and document management technology and electronic/paper publishing software
  • IT software skills
  • Ability to work with short and/ or changing timelines
  • Attention to details, highly organized, able to plan and control own workload effectively and manage expectation of others
  • Excellent written and verbal communication skills

What we offer our consultants at Experis

As a consultant at Experis, we offer you the opportunity to develop your skills on behalf of some of the largest companies in several different industries. We have high expectations of you, but in return we offer excellent development and career opportunities. Here you also get a development plan, so both you and your consultant manager understands what you want to achieve and which skills you want to develop.

Our consultants have a secure job with all that implies in terms of overtime, vacation, pension and insurance under the collective agreement

Application

Unfortunately, we can not receive your application by email, but apply through the application field through this advertisement. The selection process is ongoing, so it's important that you submit your application as soon as possible.

If you have questions regarding the consultancy role you are welcome to email Talent Acquisition Specialist Viktoria Vershovsky at viktoria.vershovsky@se.experis.com

Welcome with your application!