Jobbtitel: Regulatory Affairs Assistant at AstraZeneca

Arbetsbeskrivning:

Regulatory Affairs

On behalf of AstraZeneca we are now looking for candidates for a 12 month consultant assignment within Regulatory Affairs. During this assignment you will have a position as Regulatory CMC Associate within Chemistry, Manufacturing and Controls (CMC) Compliance Management. You will work in a team that define and manage regulatory aspects of projects and produce CMC documentation for submission to Health Authorities worldwide.

Main duties:

• Produce and support the production of Chemistry, Manufacturing and Control (CMC) documentation for designated commercial products at various stages of product life-cycle, in the required format and to the agreed timetable.

• Coordinate assembly and / or generate documentation of submission-ready components to support lifecycle regulatory submissions.

• Update relevant electronic systems to be consistent with regulatory submissions and commitments.

• Checking and correction of data post migration of documents and regulatory status information to new IT systems.

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

Business: Dfind Science & Engineering

City: Södertälje

Job type: Full time

Deadline for applications: 2016-03-11

More information: Melina Arcos, phone: 073-3434337, e-mail: melina.arcos (at) dfind.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:

Dfind Science& Engineering, former Proffice Life Science is part of the Proffice Group, one of the Nordic region's largest specialists within staffing, recruitment and outplacement.

The Proffice Group consists of Proffice, Dfind and Antenn and it has over 10,000 employees in the Nordic area.

Dfind Science& Engineering is specialized in recruitment and consulting providing competences within Life Science, Science and Engineering and is a company where people make all the difference. At Dfind Science& Engineering specialists are recruiting specialists!

All our recruitment consultants , consultants and sourcing managers have a technical or scientific background, combined with extensive networks within relevant communities and expertise within recruitment and HR. We understand our customers specific requirements and know how to find the best candidates. Through our passionate commitment and high degree of attentiveness we help people and businesses to grow and be competitive in a changing world.

Timmar per vecka: Heltid Tillsvidare

Arbetsgivare Namn: Dfind Science & Engineering AB

Arbetsgivare adress: Lunagallerian 1 15172 SÖDERTÄLJE

Form av kontakt:
Melina Arcos titel : telefon 1: () telefon 2: () mobil: e-post: melina.arcos (at) dfind.se

Jobb kort beskrivning:
Biologists, botanists, zoologists and related professionals

Land: Sweden

Område: Stockholms län

Avtalstid: Permanent

Typ av kontrakt: Full time

Källa till jobberbjudande: Public Employment Service of Sweden(AMS)

Hur man ansöker: Other - see free text