Jobbtitel: Regulatory Affairs Team Leader

Arbetsbeskrivning:

PROFIL DISCRIPTION

The team leader supports the day-to-day work in the team by coaching, prioritizing and allocating resources within the team. The position is reporting to the Head of Regulatory Affairs.

The Team Leader is also fully operational with a product portfolio.

ESSENTIAL DUTIES AND RESPONSIBILITIES

.Compiling and coordination of variations in close cooperation with the central Regulatory Affairs team

.Compiling Summaries of Product Characteristics (SPCs), patient information leaflets (PILs) and labelling texts and keeping them up to date

.Approving artwork and proof reading

.Training and support for new employees and junior members of the team

.The local regulatory expert for central functions as well as the

Health authority

.Archiving, tracking and databases

.Writing and updating processes/procedures

.Where appropriate, providing information for doctors, pharmacies and the general public about medical and pharmaceutical-related issues with regard to the company's products.

.Monitor updated requirements, current regulations and developments within the field of regulatory affairs, including interpretation of relevant regulations and guidelines.

.Responsibility for all other tasks that may arise within a registration department

SKILLS AND ABILITIES

We are looking for someone with at least 5 years of experience of Regulatory Affairs and has the following key features:

.Organized, attention to details while handling multiple tasks

.Service minded and strong interpersonal skills

.Self-motivated, positive and flexible

.Independent, reliability and demonstrating ownership

.Strong computer skills including Microsoft Office

.Fluent in Swedish and English (written/spoken). An additional Nordic language is a merit. A test will be performed to ensure good knowledge in English according to Mylan requirements.

Merit: To be discussed

Working hour: Office hours. The position is based in the office in Stockholm.

Vi intervjuar kandidater löpande för denna rekrytering och ser fram emot att ta emot din CV och personligt brev så fort som möjligt för att förstå bättre varför du är intresserade av just den här möjligheten och vad du kan bidra med.

Arbetsgivare Namn: Docs International

Arbetsgivare adress: 16973 SOLNA

Form av kontakt: Sofie Andersson e-post:

Arbetsgivare telefonnummer: 0-0

Jobb kort beskrivning: Sales and marketing managers

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