Regulatory CMC Associate DIrector
AstraZeneca AB / Kemistjobb / Södertälje
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hela Sverige AstraZeneca are pioneers in science, we strive to lead in our disease areas and transform patient outcomes. Our company's aim is to deliver 20 new medicines and be carbon negative by 2030.
At AstraZeneca we're dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There's no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth and development.
We are now looking to recruit a Regulatory CMC Contract Manufacturing Organisation (CMO) Associate Director to join our team.
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.
CMC RA Contract Manufacturing Organisation (CMO) is part of the CMC RA team Business Development team, supporting the bridge between internal functions and external customers in delivering AZ externalisation strategy.
What you'll do
The CMC RA CMO Associate Director will provide regulatory strategic guidance across the AZ externalised synthetics portfolio to deliver the needs of both AZ business and the customer.
You will be responsible for managing complex situations representing the CMC RA CMO Support function, ensuring that project activities and documentation are delivered according to business needs.
You will proactively partner with stakeholders across the AZ organisation to help deliver and implement innovative risk-based regulatory strategies. With this in mind, you have effective levels of interactive communication with a large network and you have strong influencing skills.
Additional to this you will:
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Be accountable for the provision of expert regulatory strategic guidance on documentation for CMC regulatory submissions. This should be to agreed timelines and fit for the intended purpose with appropriate consideration of the desire for subsequent operational flexibility.
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Provide expert support and advice on change management as needed to change control owners, reviewing global regulatory requirements and influencing customers as appropriate.
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Act as business owner for critical business processes to ensure regulatory compliance on behalf of the customer
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Represent CMC CMO team in cross functional global networks, communicate and provide relevant updates to the CMC team
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Be the first point of contact into CMC RA CMO Support for issues requiring support and advice outside established processes or escalation into the Global CMC RA Organisation
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Lead knowledge sharing and provide coaching both within CMC RA Business Development Group and the wider business functions
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Highlight resource needs for the externalised portfolio as appropriate for effective planning purposes
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Be dedicated to pushing the boundaries to constantly and continuously improve according to LEAN principles
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Apply GxP principles according to the stage of product lifecycle
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Apply an appropriate level of risk management across all activities
Essential for the role
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Degree or equivalent professional qualification in a science or technical field such as pharmacy, biology, chemistry, or biological science.
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Breadth of knowledge of manufacturing, project, technical and regulatory management.
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Strong understanding of regulatory affairs globally
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Stakeholder & Project management experience, with the ability to adapt to changing situations to ensure timely delivery
Desirable for the role
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Direct Regulatory Affairs CMC experience with submissions for Synthetics and/or biologic and biotechnology derived products
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Understanding of regulations and guidance governing the manufacture of medicinal products
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Professional Capabilities such as: Lean Approach, Problem solving, Quality and Compliance Management, Quality Risk Management and managing resource requirements for pivotal projects.
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Experience of working with external partners to AstraZeneca.
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Strong influencing skills
The position can sit at our locations in Gärtuna or Gothenburg, Sweden or Macclesfield, UK.
Why AstraZeneca?
Here you'll have the opportunity to make a meaningful difference to patients' lives. Build unrivalled capabilities in a place that promotes learning agility and offers development opportunities. We never stand still so you'll have the chance to constantly grow your abilities, skills and knowledge. Here we are a fusion of challenging and interesting work, in an energising and inspiring environment. Embrace the opportunity for development - whether that's upskilling or reskilling. We are reimagining what a culture of lifelong learning means. Because we want all our people to embrace the challenges and opportunities that lie ahead. This is the place to build a long-term career. Interested? Come and join our journey.
So, what's next?
Are you already imagining yourself in this position? Good, because we can't wait to hear from you!
Welcome with your application; CV and cover letter, no later than November 22, 2022.
Varaktighet, arbetstid
Heltid Permanent
Publiceringsdatum2022-11-08ErsättningNot Specified
Så ansöker duSista dag att ansöka är 2022-11-22
Klicka på denna länk för att göra din ansökanFöretagAstrazeneca AB
Arbetsgivarens referens Arbetsgivarens referens för detta jobb är "R-151973".
Omfattning Detta är ett heltidsjobb.
Arbetsgivare Astrazeneca AB (org.nr 556011-7482)
Arbetsplats AstraZeneca
Kontakt AstraZeneca
nadja.bergman@astrazeneca.com Jobbnummer 7151164
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