Regulatory Account And Line Manager, Gqsc, Operation Regulatory
AstraZeneca / Apotekarjobb / Södertälje
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hela Sverige 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. We're more than one of the world's leading pharmaceutical companies though; at AstraZeneca, we're proud to have a unique workplace culture that inspires innovation and collaboration. Here, employees are empowered to express diverse perspectives - and are made to feel valued, energized and rewarded for their ideas and creativity.
Operations Regulatory is a global function that manages all Chemistry, Manufacturing and Controls (CMC) post-approval regulatory activities across AstraZeneca's global supply chain.
We are now looking for a Regulatory Account and Line Manager. The role holder will be responsible for a team of approximately 11 CMC experts responsible for managing post approval CMC (Chemistry Manufacturing & Control) maintenance activities/projects. You will also support the project portfolio for which the team is accountable. The position is a temporary position and based in Södertälje, Sweden.
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 be representing GQSC(Global Quality Supply Chain)/Operations Regulatory 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.
You will report to Head of TA RIA and play a key role in the product leadership team.
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 Operations Regulatory
Provide AZ technical functions clear concise guidance on current regulatory requirements 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 Cecilia Just Davies tel +46 709 154549.
Welcome with your application no later than the 10th of February.
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 Temporary
Publiceringsdatum2019-01-21ErsättningNot Specified
Så ansöker duSista dag att ansöka är 2019-02-11
Ange följande referens när du ansöker: R-043350
Klicka på denna länk för att göra din ansökanKontaktAstraZeneca
karin.serden@astrazeneca.comFöretagAstraZeneca
AdressAstraZeneca
15185
15185 0181
KontorsadressAstraallén, 15185 Södertälje
Jobbnummer 4567667
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