Regulatory CMC Associate at AstraZeneca

Regulatory Affairs Assistant
Regulatory CMC Associate, Global Quality Supply Chain – Operations Regulatory

Temporary position



We are now looking for candidates for a consultant assignment within Regulatory Affairs, planned to last until August 2020. You will be employed by Randstad Life Sciences and this will be your first assignment. As our consultant you get a secure employment with collective agreements (Almega), fixed monthly salary and benefits such as healthcare, occupational health insurance, insurance, ITP pension and health care allowance.

Randstad Life Sciences is a consulting and recruitment company specialized in science and technology skills. We arrange various events and training courses for our consultants that enable exchange of experience, networking and insight into working in different roles and companies. With us, you get a consultant manager who is committed to your assignment and career development.


About AstraZeneca

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 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 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




Business: Randstad Life Sciences

City: Södertälje

Job type: Full time

Deadline for applications: 2019-07-02

More information: Melina Arcos, melina.arcos@randstad.se



Please send your application in English.

We encourage you to send your application as soon as possible, since interviews and candidate selection are done continuously! We put great emphasis on personal suitability for this role.



Organization/Business description:

With more than 600 000 employees in 38 countries, Randstad is the global leader in the HR services industry and offers staffing, consulting and recruitment solutions in all areas of expertise. We also offer interim management, executive search and outplacement services. We have a large network of clients and candidates, which means that we convey hundreds of jobs within different industries all over Sweden. Our ambition is to be the best employer in the market.

By combining our passion for people with the power of today’s technology, we help people and organizations to reach their true potential. We call it Human Forward.