Regulatory Affairs Manager at AstraZeneca

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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.

Business: Proffice Life Science



City: Göteborg



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:

• 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



Deadline for applications: 2014-05-08



More information: Camilla Bågenholm 0733-434777 or Birgitta Nyström 0733-434153.



Organization/Business description:
Proffice Life Science is the leading Nordic specialist of temporary recruitment services within the Biotech and Chemtech industries. We are able to provide our Nordic clients with highly skilled and experienced specialists from all over Europe.

All consultants, employed by Proffice, are specialists. Proffice is one of the largest and most well-renowned staffing agencies in Sweden. All consultants, hired by Proffice, have secure and permanent employment contracts with a certified staffing agency. We offer excellent benefits and personal development opportunities within a wide range of positions and industries.

Our clients expect only the best from Proffice and we expect only the best from our consultants. As you will spend your working day on our clients’ premises, you will have to not only be an expert in your field, but also a flexible, independent and social member of the team. You thrive on new challenges and welcome new opportunities. If this appeals to you, we offer a stimulating job, with excellent benefits such as private medical insurance, discounted gym membership and further contributions to health care related activities.

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