CMC Regulatory Account & Line Manager
AstraZeneca / Kemiingenjörsjobb / Södertälje
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hela Sverige We are looking for a new Regulatory Account Manager responsible for managing post approval CMC (Chemistry Manufacturing & Control) maintenance activities/projects. The position is based in Södertälje, Sweden.
As Regulatory Account Manager you will be line-managing a team of Regulatory CMC Managers and Regulatory CMC Associates in order to deliver the project portfolio for which the team is accountable.
You will be responsible for providing operational, tactical and strategic CMC regulatory expertise and direction to product and project teams in support of products throughout the product lifecycle.
You will report to Head of TA CVRM and play a key role in the product leadership team.
You will be representing CMC Regulatory Compliance in global cross functional teams such as the Global Supply Teams (GST). You will also be expected to work closely with other regulatory functions in AZ, as well as the manufacturing sites.
Responsibilities will include
* Line -management and development of a team of professional regulatory staff.
* Responsible for defining the content of CMC submissions (NDA, MAA, JNDA, variations, Annual Reports, Licence Renewals etc) on behalf of CMCRC.
* Provide AZ technical functions clear concise guidance on current regulatory requirements to to support business tactical and strategic planning.
* Ensure expert recommendations and decisions relating to CMC for individual products/product portfolios including risk management and mitigation.
* Ensure projects are delivered to agreed time-scales, AstraZeneca business requirements, compliance requirements and regulatory authority expectations worldwide.
Minimum Requirements - Education and Experience
* Degree, or equivalent, in Chemistry or Pharmacy or Chemical Engineering
* Excellent written and verbal Swedish and English
* A minimum of 12 months experience in line management
* A minimum of 12 months experience in Pharmaceutical Production or Quality Assurance or Quality Control or Product Maintenance or Regulatory Affairs
Skills and Capabilities
* Experience of line management
* Excellent communication skills
* Team working skills
* Ability to make effective decisions despite uncertainty and/or incomplete information to drive business outcomes
* Ability to establish fruitful relationships and maintain networks
* Ability to work with short and/ or changing timelines
More information
For more information about the position please contact Fiona Moran, tel +44 7990 648545.
Welcome with your application no later than July 22, 2018.
About us
In Södertälje, Sweden, is AstraZeneca 's largest global production and distribution facility, one of the world's largest manufacturing units for pharmaceuticals. In total, we employ approximately 4,100 people, of which 3,500 are working in the manufacturing facilities.
In Södertälje, we are also investing about $285 million in a new high technology facility for manufacturing of biomedicine, which enables us to combine our expertise within Biomedicine and our well-established, first-class production culture.
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status or any other.
Varaktighet, arbetstid
Heltid Permanent
Publiceringsdatum2018-06-25ErsättningNot Specified
Så ansöker duSista dag att ansöka är 2018-07-16
Ange följande referens när du ansöker: R-030647
Klicka på denna länk för att göra din ansökanKontaktAstraZeneca
lena.ljungquist@astrazeneca.comFöretagAstraZeneca
AdressAstraZeneca
15185
15185 0181
KontorsadressAstraallén, 15185 Södertälje
Jobbnummer 4220565
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