Regulatory Affairs Manager
Experis Engineering Huvudkontor / Kemiingenjörsjobb / Södertälje
2016-01-04
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➡️ Klicka här för den senare publicerade platsannonsen "Regulatory Affairs Manager" (publicerad 2016-01-18) ⬅️
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Botkyrka,
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hela Sverige Experis Engineering offers skills of technical managers and professionals through consulting, recruiting and project solutions. By combining our industry experience with our knowledge of the human potential, we both let individuals and businesses to grow and develop. Experis Engineering is located at 30 locations in Sweden and in more than 50 countries worldwide.
Experis engineering in Stockholm are expanding our successful team! For our big customer within the medtech industry we are now seeking for a Regulatory Affairs Manager for a one year assignment starting immediately.
Work description
The assignment is to coordinate and execute all regulatory tasks in the delivery of submissions. This means that:
• You are responsible for management and coordination of the regulatory submissions sent to health authorities.
• You provide operational regulatory input and guidance in cross-functional teams.
• You work flexibly within and across Therapeutic Areas to contribute in business decisions, including brand teams, with regulatory insights and understanding for the regulatory framework.
• You understand the EU regulatory procedures and apply this knowledge in your daily work as well as when strategizing long term.
• You work in a structured way assuring all steps in a task are performed timely.
• You understand and comply with the ways of working and strive for improving those.
• You identify opportunities as well as show stoppers in business related or compliance related areas.
• You master the electronic archiving functionality in the Regulatory function, and you make it easy for others to operate by keeping the structure and good order.
Who are you?
• Master's degree in Pharmacy, Chemistry, Biology or equivalent
• Demonstrated experience with Regulatory work by 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
• Excellent knowledge of English and at least one of the Nordic languages
• Good knowledge of relevant legislation requirements and procedures
• Strong ability to work collaboratively
Desirable
• Experience from pharmaceutical development, manufacturing
• Experience from health authority work
• Solid business acumen and a good RA toolbox to apply
• Good at influencing and building relationships with senior stakeholders
• Ability to plan, communicate and drive processes and projects all the way to the finish line
What can we offer?
Let Experis open the doors to your dream company. We cooperate with many of Sweden's most popular companies and can offer you:
• Ability to work in Swedish and international environment.
• Exciting assignments on the markets most interesting companies.
• Development opportunities on both long and short term.
• Networking with people in your profession through both networking events and social activities.
Our business is based on our employees feel comfortable and want to stay with us. Our consultants have a secure job with all that implies in terms of overtime, vacation, pension and insurance under the collective agreement. Contributions wellness and occupational health are examples of other things that we offer all our employees.
Contact person
Welcome with your application. Please note that we only accept applications through our website. Selection is ongoing, then the assignment will be appointed immediately. Do you have questions about the role of consultant at Experis, please contact Talent sourcer Jonas Andersson på
jonas.andersson@se.experis.comWelcome with your application!
Varaktighet, arbetstid
100% Enligt överenskommelse
Publiceringsdatum2016-01-04ErsättningEnligt överenskommelse
Så ansöker duSista dag att ansöka är 2016-01-12
Klicka på denna länk för att göra din ansökanKontaktJonas Andersson 031-617205
FöretagExperis Engineering Huvudkontor
AdressExperis Engineering Huvudkontor
Klarabergsgatan 29
11181 Stockholm
KontorsadressKlarabergsgatan 29
Jobbnummer 2599448
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