Experis Engineering are currently looking for a driven and competent Regulatory CMC Associate for AstraZeneca in Södertälje. Do you want to take your next career step within life science at an exciting and reward-winning company? Then this job is just right for you! Please make sure to send in your application as soon as possible, selections are made continuousely.
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 severe 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 within Global Quality Supply Chain, that manages all Chemistry, Manufacturing and Controls (CMC) post-approval regulatory activities across the world-wide AstraZeneca supply chain.
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 within AstraZeneca 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.
The role will be based in Södertälje, Sweden, and you will work in a team of 8-10 people.
Minimum Requirements - Education and Experience
- Degree in Chemistry, 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
- 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
- Good communication skills
- Knowledge of information and document management technology and electronic/paper publishing software
- IT software skills
What can Experis offer you?
As a consultant at Experis Engineering we are happy to offer you the opportunity to develop your knowledge within different fields at some of Sweden's leading companies. At Experis we are very proud of our consultants and together we find the right career-paths and challenges for you!
We do have high expectations on you, and in return we offer you great possibilities and opportunities in your work-life. We work together by setting plans for you on how we can collaborate for you to reach your own personal goals and develop professionally.
At Experis we strive for a good work and life balance. You will get a permanent employment in accordance with union agreements, including overtime payment, vacation, occupational pension and insurances.
Contact and application:
Please send in your CV as soon as possible through the link on the page. We do not have the possibility to receive applications through e-mail, but should you have questions about the job or the role as a consultant at Experis, please feel free to contact Talent Acquisition Specialist Camilla Forssberg at Camilla.Forssberg@se.experis.com or 08-736 19 23.