Global Head Submission Management Group
R&d Mölndal / Läkarjobb / Mölndal
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Department: Global Regulatory Operations - Submission Management Group
Reports to: VP Global Regulatory Operations
Location: SE-Molndal or US-Wilmington
Number of Positions: 1
Band: F/7
Description:
To lead, develop and provide strategic direction to the Submission Management Group and lead the development of the global capability and associated processes (including resource allocation) to optimally support the delivery of AZRA's vision and mission.
Accountabilities/Responsibilities:
Lead and develop the Submission Management Group globally with a staff of approx 60 individuals located in Sweden and the US
Recruit and develop staff in partnership with HR business partners according to agreed head count plan
Key member of the Leadership for the Global Regulatory Operations Group and as such take part in the collective leadership of the group
Represent AZRA on appropriate internal and external bodies and activities
Responsible for managing the SMG global budget
Initiate and lead efficiency and effectiveness projects with clear business priorities within SMG
Establish a culture of high performance, flexibility and quality emphasising a "can do" attitude and innovative approaches
Ensuring that SMG take the full responsibilities for the technical format of all submissions
Ensuring that SMG interacts with Health Authorities in matters related to technical formats of submissions
Influence and/or provide background for e-Regulatory discussions with Health Authorities on a global level
Ensure a performance driven culture in the group with clear individual objectives, IDPs and consistent talent management
Ensuring full awareness of and adherence to AZ group policies in SMG as well as full implementation of Corporate Responsibilities
Initiate clear and efficient processes for SMG including enhancing and maintenance of existing processes
Responsibility for full implementation of relevant processes
Preferred Background
Degree and/or PhD in scientific discipline or equivalent
10 years experience or equivalent of regulatory drug development including submissions for product approval. Experience from other areas in pharmaceutical business. Line management experience. International work experience
Skills and Experience
Proven leadership skills in accordance with AstraZeneca leadership capabilities
Excellent influencing and negotiation skills
Communication/Presentation skills (including fluent verbal and written English)
Proven people and project management skills
Extensive knowledge of regulatory procedures
Extensive knowledge of drug development/approval process
Knowledge and experience of the most appropriate mechanisms for influencing the external environment
Direct experience of Information / Document Management
Internal and External Contacts/Customers
R&D organization AZ
Regulatory authorities
Reporting Relationship
Direct Reports: 1 Director Group Manager and 5 Associate Director Group Managers
Indirect Reports: approximately 60 staff in global professional delivery roles
More Information
For more information please contact Gunilla Bergfelt, +46 31 776 1027.
Welcome with your application no later than 4th January, 2012.
For application please visit
www.astrazeneca.sePubliceringsdatum2011-12-14Arbetstider och omfattningTillsvidare
Heltid
ErsättningFast lön
Så ansöker duSista dag att ansöka är 2012-01-04
Ansökan kan endast ske via
www.astrazeneca.seAnge följande referens när du ansöker: MOL000000QG
Ansökan kan tyvärr inte göras via e-post.
FöretagR&D MÖLNDAL
AdressR&D MÖLNDAL
43183 MÖLNDAL
KontorsadressPEPPAREDSLEDEN 1
MÖLNDAL
KontaktuppgifterTelefonnummer: 031-7761000
Jobbnummer 1105397
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