Regulatory Affairs Associate to AstraZeneca!
Adecco Sweden AB / Kemiingenjörsjobb / Södertälje
2016-12-22
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hela Sverige Adecco Life Science is now recruiting a Regulatory Affairs Associate to our customer AstraZeneca in Södertälje. This is a consultant assignment which is planned to start as soon as possible and continue for approximately one year.
AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines for some of the world 's most serious diseases. AstraZeneca is one of the world 's leading pharmaceutical companies. At AstraZeneca, we promote a culture that inspires innovation and collaboration.
The Arena
AstraZeneca has decided to divest some of the products that are currently in our portfolio to enable resources and support the strategy of launch of new products in line with our core therapeutic areas. The Regulatory Affairs Associate will work in close cooperation with the Regulatory Affairs Managers and with other functions within our Nordic-Baltic Marketing Company, to support efficient management of divestment projects. In addition, he/she will support with efficient and timely regulatory processes for successful launches and lifecycle management of products in the AZ portfolio. He/she will provide regulatory input to support across the organization to ensure that our products meet all regulatory requirements and with the focus on patients access to safe medicines.
Description
The assignment is to work with regulatory activities for divestment projects, but also to support the Regulatory department with different type of submission related activities for our products. This means that:
* You coordinate projects, prepare documents and submissions to Health Authorities in connection to divestment projects.
* You work flexibly within the Regulatory Team and support and contribute with regulatory activities and insights, including support and guidance to cross-functional teams.
* You work with preparation of labelling documents for artwork for products on market.
* You work in a structured way assuring all steps for a task are performed in a timely manner.
* 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 tools and functionalities in the Regulatory function, and you make it easy for others to operate by keeping the structure and good order.
Typical accountabilities and responsibilities
* Responsible for preparation of regulatory submissions to support divestment projects and supporting high quality submissions and fast approvals
* Communicates with authorities on pending issues and requirements; drives and develops key AZ specific regulatory questions and processes
* Continuously updates stakeholders and TA teams on regulatory requirements and timelines for completing / managing regulatory activities in connection to divestment projects
* Ensures that product information, labelling, artwork and other materials meet external requirements and AZ policies
* Works in close cooperation with European and global regulatory colleagues
* Contributes to the development of an effective team
* Ensures personal competence development
* Contributes to the overall development of the department and positive attitude towards working and developing
* Actively contributes to continuous improvements within the function
* Assures tasks are of correct quality and in accordance with written procedures and current legal requirements and internal standards
Education and Experience, essential
* Bachelor 's degree or 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 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 or quality assurance
* 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
Key relationships to reach solution
Internal:
* Global Regulatory Affairs teams
* European Regulatory Affairs
* Regulatory CMC teams
* TA teams/Business Units
* Medical function
* Logistic function
* Marketing and Market Access
* Production sites
External:
* Labelling and translation CRO
* National Health Authorities
* Local / National trade associations and working groups
What do we offer?
Adecco Life Science is a specialized Business Line within Adecco. We work exclusively with Staffing Services and Recruitment of personnel within the Life Science industry. Our expertise lies within all areas of Life Science such as R&D, Production, Quality Assurance, Clinical Research, Regulatory Affairs, Medical Affairs, Marketing & Sales and many more. Our customers are companies, of different sizes, within the Pharmaceutical-, Biotech- and Medtech- industries. As the largest recruiting and staffing company in the world our most valuable assets are our consultants. With us, you as a consultant will be appreciated for your difference-making competence within Life Science!
Adecco Life Science can offer you the opportunity of interesting assignments and positions at attractive companies that perhaps never will be put out on the open market! For your security as a consultant, you are covered by our collective agreement and by insurance and corporate healthcare. We also want you to stay healthy and therefore offer you healthcare contributions and discounts on training cards. We arrange social activities continuously where you are able to share your experiences with our other consultants.
Are you interested?
Then you should apply as soon as possible. The position is soon to be filled and therefore work with recruitment is being done on a continual basis.
Unfortunately we can not accept applications through e-mail, but if you have questions regarding the position contact Heidi Pettersson,
heidi.pettersson@adecco.se.
We look forward to your application!
Varaktighet, arbetstid
Heltid Tillsvidare
Publiceringsdatum2016-12-22ErsättningFast lön
Så ansöker duSista dag att ansöka är 2017-01-15
Klicka på denna länk för att göra din ansökanKontaktHeidi Pettersson
Heidi.Pettersson@adecco.seFöretagAdecco Sweden AB
AdressAdecco Sweden AB
Kungsgatan 60
10224 STOCKHOLM
KontorsadressKungsgatan 60
Jobbnummer 3229548
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