CMC Regulatory Affairs Associate Team Manager
AstraZeneca AB / Kemiingenjörsjobb / Södertälje
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hela Sverige Do you want to combine your scientific background with your passion for people and people development? We are looking for a Chemistry, Manufacturing and Controls (CMC) Regulatory Affairs Associate Director and Team Manager to support and lead a team of approximately 10 CMC specialists which is responsible for managing CMC submissions across the product lifecycle. The position is permanent and based in Södertälje, Sweden.
Our Södertalje site in the county of Stockholm is host to one of the largest manufacturing units of pharmaceuticals in the world - and the largest in all of AstraZeneca. It's no wonder we're known as the 'heart of production'. From chemical production, formulation and packing, to marketing, sales, and delivery, on this site, we handle the whole process.
Our Chemistry, Manufacturing, and Controls (CMC) Regulatory functions span across the product lifecycle and are responsible for the regulatory strategy relating to the development, manufacture and testing of all of our medicines. With our expertise we interpret, anticipate and shape global Health Authority expectations to create insightful CMC and Device Regulatory Strategies. We are the bridge between our R&D functions, Operations sites, Quality and Global Supply Teams in helping safe, effective medicines reach the right patient at the right times.
What you'll do
In this Associate Director and Team Manager role you will possesses strategic leadership skills and be accountable for leading a team of Regulatory professionals ensuring delivery of global CMC regulatory submissions for a product/group of products across the product lifecycle based on the needs identified by the business, markets and patients.
You will prioritise the teams work in order to deliver the needs of both the AZ business and the customer, providing operational, tactical and strategic regulatory CMC expertise and direction in support of CMC projects. You will also apply Lean Principles to ways of working and foster a positive working environment that supports continuous improvement and simplifications.
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To provide overall direction, develop and line manage a group of regulatory CMC experts within the CMC Regulatory Affairs organization.
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Ensure project activities managed within the team are delivered to a high standard, agreed time scales and meet the AZ business requirements, compliance requirements and regulatory authority expectations worldwide.
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Lead cross SET non-drug projects and act as business owner for critical business processes to ensure accelerated submissions, support launch activities and management of regulatory information and ensure regulatory compliance on behalf of AZ.
Essential for the role
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BS/MS or Ph.D. in a scientific discipline
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Experience working directly in CMC Regulatory Affairs or Pharmaceutical Production or Quality Assurance or Quality Control or Product Maintenance
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Excellent written and verbal English
Desirable for the role
No matter where your strength lies you need a can do-attitude, seeing opportunity rather than obstacles and possess great interpersonal skills. To be passionate about the team's development is absolutely critical, both on a broader strategic level and for each team members own development. You have excellent communication skills and the ability to make effective decisions despite uncertainty and/or incomplete information to drive business outcomes.
It's a big plus if you have experience or interest in the LEAN concept and understand how this can be adapted to an office-based environment.
Why AstraZeneca?
Our purpose is ambitious and so is our approach. Becoming a more agile and innovative company means building a dynamic, inspiring culture where we celebrate forward thinking and act with a sense of urgency. We are ambitious, take informed risks and learn from both success and failure. We are curious, creative and open to new ideas and ways of working. Above all, we are passionate about science and driven to always put patients first. Are you ready to move forward in your career?
Join us and be part of an outstanding place to work; an environment that energizes and empowers each of us to achieve our personal and organisational goals!
So, what's next?
Are you already imagining yourself joining us? Good, because we can't wait to hear from you!
Welcome with your application; CV and cover letter, no later than February 13th, 2022.
Where can I find out more?
AstraZeneca:
https://www.astrazeneca.com/Follow AstraZeneca on LinkedIn
https://www.linkedin.com/company/1603/Follow AstraZeneca on Facebook
https://www.facebook.com/astrazenecacareers/Follow AstraZeneca on Instagram
https://www.instagram.com/astrazeneca_careers/?hl=enVaraktighet, arbetstid
Heltid Permanent
Publiceringsdatum2022-01-21ErsättningNot Specified
Så ansöker duSista dag att ansöka är 2022-02-11
Klicka på denna länk för att göra din ansökanFöretagAstrazeneca AB
Arbetsgivarens referens Arbetsgivarens referens för detta jobb är "R-128650".
Omfattning Detta är ett heltidsjobb.
Arbetsgivare Astrazeneca AB (org.nr 556011-7482)
Arbetsplats AstraZeneca
Jobbnummer 6271107
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