Regulatory Affairs Managers for future assignments at AstraZenec

Dfind Engineering / Apotekarjobb / Göteborg
2014-09-11
Observera att sista ansökningsdag har passerat.
➡️ Klicka här för den senare publicerade platsannonsen "Regulatory Affairs Managers for future assignments at AstraZenec" (publicerad 2014-09-23) ⬅️


Visa alla apotekarjobb i Göteborg, Mölndal, Partille, Kungälv, Lerum eller i hela Sverige
Visa alla jobb hos Dfind Engineering i Göteborg, Alingsås, Borås, Herrljunga, Ulricehamn eller i hela Sverige

Regulatory affairs manager
For future assignments at AstraZeneca we are now looking for Regulatory Affairs Managers. The Regulatory Affairs Manager  is responsible for project management and coordination of  the content of regulatory submissions sent to health authorities. The individual will ensure that products meet all legal requirements, both regarding new products as well as for new indications, new markets license renewal, etc.

Business: Dfind Science & Engineering

City: Göteborg

Responsibilities:

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
• 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
• Monitor, interpret and validate current and changing regulatory legislation and share potential impact these activities may have on the product development program

Minimum Requirements - 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.
• Experience from Regulatory Affairs from medical device or the pharmaceutical business.

Personal Qualities:

We put high importance in personal qualities. Candidates should possess good social skills and be strong team players. You should be able to work independently, take own initiatives and have a positive, goal oriented and problem solving attitude. It is essential to have good organizational and communication skills.

Deadline for applications: 2014-09-21

Information: Per Hillertz, per.hillertz@dfind.se [ mailto: per.hillertz@dfind.se ] or Eleonor Ehrman, eleonor.ehrman@dfind.se [ mailto: eleonor.ehrman@dfind.se ]

Organization/Business description:
Dfind Science & Engineering is a staffing and recruitment company with competences within science and engineering as our specialization. Our commitment and service help people and companies to find solutions to develop.

Publiceringsdatum
2014-09-11

Arbetstider och omfattning
Heltid Visstid

Ersättning
Fast lön

Så ansöker du
Sista dag att ansöka är 2014-09-21
Ange följande referens när du ansöker: 200637222
Klicka på denna länk för att göra din ansökan

Kontakt
Eleonor Ehrman eleonor.ehrman@dfind.se

Företag
Dfind Engineering

Adress
Dfind Engineering
Östra Hamngatan 23
41110 GÖTEBORG

Kontorsadress
Östra Hamngatan 23, 41110 GÖTEBORG

Jobbnummer
1993331

Observera att sista ansökningsdag har passerat.

Prenumerera på jobb från Dfind Engineering

Fyll i din e-postadress för att få e-postnotifiering när det dyker upp fler lediga jobb hos Dfind Engineering: