Regulatory Affairs Manager, Nordic Baltic Market
AstraZeneca Södertälje / Säljarjobb / Södertälje
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As a part of AstraZeneca, the Nordic-Baltic Marketing Company is working to ensure that our innovative products reach the patients that can benefit from it. We work in close collaboration with healthcare in all Nordic and Baltic countries to build value for our customers and success for our medicines. Our offices are located in Södertälje, Copenhagen, Helsinki, Oslo, Tallinn, Riga, and Vilnius.
The Role
The Regulatory Affairs Manager ensures efficient and timely regulatory processes with successful launches and lifecycle management. He/she will provide regulatory expertise to support across the organization to ensure that our products meet all regulatory requirements and with the focus on patients access to safe medicines.
The position is located in Södertälje, Sweden.
Typical Accountabilities and Responsibilities
Responsible for regulatory submissions both on new and established products 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
Coordinates and develops contacts to regulatory authorities
Continuously updates stakeholders and TA teams on regulatory requirements and timelines for completing / managing regulatory activities
Ensures texts and other materials meet external requirements and AZ policies (e.g. labelling including product information and compendial texts)
Works in close cooperation with European and global regulatory colleagues
Follows up trends and changes in regulation; does competitive intelligence within the field of regulatory responsibility
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
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
External
Labelling and translation CRO
National Health Authorities
Local / National trade associations and working groups
More information
For more information about the position please contact Victoria Eriksson, +46 (0)733 54 22 09.
Welcome with your application no later than August 14, 2016.
Varaktighet, arbetstid
Visstidsanställning 6 månader eller längre
Heltid
Publiceringsdatum2016-07-08ErsättningFast månads- vecko- eller timlön
Så ansöker duSista dag att ansöka är 2016-08-14
Ange följande referens när du ansöker: SOD000002HV
FöretagAstraZeneca Södertälje
AdressAstraZeneca Södertälje
Karlebyhus, Astraallén
15185 Södertälje
Övriga kontaktuppgifterTelefonnummer: 08-553 260 00
Jobbnummer 2948391
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