Regulatory CMC Associates

Presentation
On behalf of our client, AstraZeneca, we are now looking for a Regulatory CMC Associates for a temporary assignment. The position will be based in Södertälje and you will work in a team of 8 - 10 people. This role offers great opportunities for you to work with global networks, as a member of the CMC Regulatory Compliance organization within the company. CMC Regulatory Compliance is a global function that manages all Chemistry, Manufacturing and Controls (CMC) post-approval regulatory activities across the global supply chain. The assignment which is full-time will start ASAP with the duration of twelve months. Selections and interviews are held on an ongoing basis, so please submit your application as soon as possible. Cover letter and CV must be in English.

Arbetsuppgifter
Candidate Focus & Challenge:
The Operations Regulatory CMC - Analyst 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.

Utbildning/erfarenhet
Skills & Experience:
- IT Software skills
- Fluently spoken and written English and Swedish
- Experience in Pharmaceutical Production or Quality Assurance or Quality Control or Product Maintenance or Regulatory Affairs Education Degree, or equivalent, in Chemistry or Pharmacy or Chemical Engineering

Other:
- Able to work collaboratively with customers and colleagues to achieve optimum outcomes
- Knowledge of information and document management technology and electronic/paper publishing software
- 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

Förmåner
We take good care of our consultants and we offer social activities, as well as help in planning your future career. Your consultant manager is well experienced from your field, and knows how to get the most out of your assignment.

As a Poolia employee, you are included in the requirements concerning agreements on terms of employment by Unionen. Moreover, you get a grant for working out at your choice of place. You are also covered by a health insurance.

Företagsbeskrivning
Poolia Life Science can offer several opportunities for skilled people with a background in biochemistry, chemical engineering or science. We work with Sweden’s leading pharmaceutical and life science companies. So whether you’re interested in research, regulatory affairs, quality assurance, environmental and quality control, sales and marketing, or just want a career change, we have the job for you.

Working as a consultant suits whoever wants to get a lot of experience in a short period of time. We offer you the chance to work with well-known brands at renowned companies where you can develop your skills. If you’re looking for a world of exciting assignments and new contacts, you’ll like being a consultant.

AstraZeneca is a major international healthcare company engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. But we are more than one of the world’s leading pharmaceutical companies - at AstraZeneca, we are proud to have a unique 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.

Sluttext
Please apply by registering your CV here on our website. Click on the "Ansök" button to the right. It is our recommendation that you register as much information as possible and that you attach a complete CV-document. Please check that your correct e-mail address is registered.

Poolia is a registered staffing agency, meaning that we comply with the requirements set by Bemanningsföretagen - the Swedish Association of Staffing Agencies.

Language
en-GB