Regulatory Affairs Manager to AstraZeneca in Södertälje!
Adecco Sweden AB / Läkarjobb / Södertälje
2015-12-09
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Salem,
Ekerö,
Nykvarn,
Botkyrka eller i
hela Sverige We are now looking for a Regulatory Affairs Manager, for a consultant assignment positioned at AstraZeneca in Södertälje. The assignment is to start as soon as we have the right candidate and proceed until January 2017.
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
The Regulatory Affairs Manager ensures efficient and timely regulatory processes with successful launches and lifecycle management. He/She will contribute to improvement by providing regulatory expertise as well as support across organization with maintaining focus on patients access and safety of medicines.
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.
Typical accountabilities and Responsibilities
• Responsible for regulatory submissions both on new and established products supporting rapid and high quality approval
• Communicates with authorities on pending issues and changes in regulatory requirements; drives and develops key AZ specific regulatory questions and processes
• Coordinates and develops contacts to regulatory authorities
• Continuously updates stakeholders and TA teams on regulatory requirements and timelines for completing / managing regulatory activities
• Ensures AZ practices / texts / other materials meet external requirements and AZ policies (e.g. labelling; compendial and translation CRO)
• Works in close cooperation with European and global regulatory
• Follows up trends and changes in regulation; does competitive intelligence within the field of regulatory responsibility
• Contributes to the development of an effective team
• Ensure personal competence development
• Contributes to the overall development of the department and positive attitude towards working and developing
• Active contribution 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
• 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 stakeholdersAbility to plan, communicate and drive processes and projects all the way to the finish line
Key relationships to reach solution
• Global Regulatory Affairs teams
• European Regulatory AffairsRegulatory CMC teams
• TA teams
• Medical function
• Logistic function
External
• Labelling and translation CRO
• National Health Authorities
• Local / National trade associations and working groups
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 soon to be filled and therefore work with recruitment is being done on a continual basis.
We look forward to your application!
Varaktighet, arbetstid
Heltid Visstid
Publiceringsdatum2015-12-09ErsättningFast lön
Så ansöker duSista dag att ansöka är 2016-01-08
Ansöker gör du genom att använda länken nedan.
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
Övriga kontaktuppgifter Jobbnummer 2568218
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