Regulatory Affairs Manager
Adecco Sweden AB / Läkarjobb / Mölndal
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hela Sverige Adecco is the largest recruiting and staffing company in the world. Adecco Life Science is one of our specialized Business Lines, which works exclusively with Staffing Services and Recruitment of personnel for the Life Science industry. Our customers are within the Pharmaceutical-, Biotech- and Medtech companies. We focus on positions within Regulatory Affairs, Medical Affairs, R&D, QA, QC, Clinical Research, Marketing and Sales. We are now recruiting a Regulatory Affairs Manager, location Mölndal. Preferably the candidate start as soon as possible and the assignment will initially continue for one year. The candidate will be employed by Adecco.
The Arena
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
• Univeristy 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.
What do we offer?
Adecco is the world's largest recruitment and staffing company and our most important asset is our qualified employees. With us, and on our customer assignments, you, as a consultant, will be appreciated for your difference-making competence! Your bank of experience will grow, as will your social and professional network of contacts. Adecco can offer you the opportunity of interesting assignments at attractive companies, of positions that perhaps never will be put on the open market.
We want you to feel good and will give you subsidies for preventive healthcare and discounts on training cards. In order for you to feel secure, you will also be covered by insurance and corporate healthcare.
Are you interested?
Then you should apply as soon as possible. The position is to be filled immediately, and, for that reason, work with recruitment is being done on a continual basis during the application period.
We look forward to your application!
Publiceringsdatum2014-05-05Arbetstider och omfattningFull Time
ErsättningAccording to agreement
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Klicka på denna länk för att göra din ansökanKontaktJenni Sventoft 08-598 98129
FöretagAdecco Sweden AB
AdressAdecco Sweden AB
Götgatan 11
41105 GÖTEBORG
Jobbnummer 1862033
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