Jobbtitel: Regulatory Affairs Manager, Nordic Baltic Market

Arbetsbeskrivning:

The Arena

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.

Arbetsgivare Namn: AstraZeneca Södertälje

Arbetsgivare adress: Karlebyhus, Astraallén 15185 Södertälje

Form av kontakt:
titel : telefon 1: () telefon 2: () mobil: e-post:

Arbetsgivare telefonnummer: 08-553 260 00

Jobb kort beskrivning:
Technical and medical sales professionals (excluding ICT)

Land: Sweden

Område: Stockholms län

Avtalstid: Permanent

Typ av kontrakt: Full time

Källa till jobberbjudande: Public Employment Service of Sweden(AMS)

Hur man ansöker: Other - see free text