Regulatory Affairs Manager at AstraZeneca

Experis Finance erbjuder kompetensförsörjning av chefer och specialister inom exempelvis Ekonomi & Redovisning, Finans, Inköp, Skatt och Risk. Det gör vi via konsultverksamhet, rekrytering och projektlösningar. Genom att kombinera vår branscherfarenhet med vår kunskap om människans potential får vi såväl individer som verksamheter att växa och utvecklas. Experis Finance finns på ett 30-tal orter i Sverige och i mer än 50 länder världen över.

We are now looking for two Regulatory Affairs Managers for assignments at AstraZeneca. The assignments will start as soon as possible and will last until May 31st 2015.

The Regulatory Affairs Manager is responsible for project management and coordination of the content of all regulatory submissions sent to health authorities and ensures that products meet all legal requirements, both regarding new products as well as for new indications, new markets license renewal, etc.


Description:

The assignment is to coordinate and execute all regulatory tasks in the delivery of submissions. This means that you will:
Prepare and deliver regulatory operational plans for allocated projects/products.
Contribute to solutions to regulatory issues.
Project manage quality regulatory submissions to agreed project targets.
Provide operational regulatory input and guidance in cross-functional teams.
Work flexibly within and across Therapeutic Areas to provide broad regulatory support to ensure the delivery of product team and business objectives.

Accountabilities and Responsibilities:

Provide regulatory expertise on regulatory submissions, health authority briefing documents and response documents
Identify potential regulatory risks to the operational plans, and propose options to mitigate risks.
Acting as a project coordinator for nominated products/projects, work effectively with global regulatory affairs personnel and with global/regional cross-functional teams to plan, prepare and deliver both simple and increasingly complex submissions which will achieve the following across a range of markets
Monitor, interpret and validate current and changing regulatory legislation and share potential impact these activities may have on the product development program
Support RAD or assume assigned responsibilities for routine and non-routine contact with health authorities and marketing companies

Education and Experience:

University Degree in Science or related discipline
Two years experience of working in one or more areas in regulatory affairs in the pharmaceutical or related industry, or experience at a health authority
Excellent written and verbal communication skills
Thorough knowledge of the drug development process
Scientific knowledge sufficient to understand all aspects of regulatory issues.
Strong ability to work collaboratively.
An important requirement is that the successful candidate has experience from Regulatory Affairs from medical device or the pharmaceutical business.

Job type: Full time

For further information regarding this assignment, please contact Åsa Mårtensson mail: amr@se.experis.com or telephone: 031-617217




Experis Finance erbjuder kompetensförsörjning av chefer och specialister inom exempelvis Ekonomi & Redovisning, Finans, Inköp, Skatt och Risk. Det gör vi via konsultverksamhet, rekrytering och projektlösningar. Genom att kombinera vår branscherfarenhet med vår kunskap om människans potential får vi såväl individer som verksamheter att växa och utvecklas. Experis Finance finns på ett 30-tal orter i Sverige och i mer än 50 länder världen över.

We are now looking for two Regulatory Affairs Managers for assignments at AstraZeneca. The assignments will start as soon as possible and will last until May 31st 2015.

The Regulatory Affairs Manager is responsible for project management and coordination of the content of all regulatory submissions sent to health authorities and ensures that products meet all legal requirements, both regarding new products as well as for new indications, new markets license renewal, etc.


Description:

The assignment is to coordinate and execute all regulatory tasks in the delivery of submissions. This means that you will:
Prepare and deliver regulatory operational plans for allocated projects/products.
Contribute to solutions to regulatory issues.
Project manage quality regulatory submissions to agreed project targets.
Provide operational regulatory input and guidance in cross-functional teams.
Work flexibly within and across Therapeutic Areas to provide broad regulatory support to ensure the delivery of product team and business objectives.

Accountabilities and Responsibilities:

Provide regulatory expertise on regulatory submissions, health authority briefing documents and response documents
Identify potential regulatory risks to the operational plans, and propose options to mitigate risks.
Acting as a project coordinator for nominated products/projects, work effectively with global regulatory affairs personnel and with global/regional cross-functional teams to plan, prepare and deliver both simple and increasingly complex submissions which will achieve the following across a range of markets
Monitor, interpret and validate current and changing regulatory legislation and share potential impact these activities may have on the product development program
Support RAD or assume assigned responsibilities for routine and non-routine contact with health authorities and marketing companies

Education and Experience:

University Degree in Science or related discipline
Two years experience of working in one or more areas in regulatory affairs in the pharmaceutical or related industry, or experience at a health authority
Excellent written and verbal communication skills
Thorough knowledge of the drug development process
Scientific knowledge sufficient to understand all aspects of regulatory issues.
Strong ability to work collaboratively.
An important requirement is that the successful candidate has experience from Regulatory Affairs from medical device or the pharmaceutical business.

Job type: Full time

For further information regarding this assignment, please contact Åsa Mårtensson mail: amr@se.experis.com or telephone: 031-617217