Senior Regulatory CMC Documentation Lead

At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you're our kind of person.

We are now recruiting a Regulatory Senior CMC Documentation Lead for a permanent position to join us in the Chemistry, Manufacturing and Controls (CMC) Documentation group in CMC Regulatory Affairs, Gothenburg/Gärtuna, Sweden.

This is a great opportunity for you, after summer holidays realising, wanting to develop within the Regulatory arena in a close partnership with scientific authors to impact enablement of clinical studies and new drug product launches. The CMC Documentation group plays a key role in ensuring that AstraZeneca's CMC regulatory submissions for both clinical trials and marketing applications are delivered. We keep pace with the evolving external regulatory environment, and exciting CMC science to ensure delivery of key CMC regulatory documentation for our exciting portfolio.

The group people manages a harmonised and effective authoring, review, approval and publishing process for the CMC elements of submissions and has accountability for the deliveries of regulatory documentation authored by Pharmaceutical Technology & Development (PT&D) and Pharmaceutical Sciences (PharmSci).

What you will do?
In this position you will support clinical trials for phase 1 to phase 4 and marketing applications to obtain our commercial manufacturing license. As a CMC Documentation Lead you will be a key member of the CMC project team and have an opportunity to develop a deeper understanding of the regulatory processes, see the full range of Pharmaceutical Development documentation provided to authorities and lead teams across PT&D, Pharm Sci and regulatory departments in R&D.

In this role you will be accountable for leading the production and delivery of CMC sections of all regulatory documents e.g. marketing and clinical study applications, responses to Health Authority questions and briefing documents. Your main responsibilities will include:

- Defining which CMC documents are required for science functions to author
-Establishing the document strategy for the project scenario
- Preparing and running the CMC Submission Kick Off and review meetings
- Leading the delivery team (authors, reviewers, approvers) for the CMC part of submissions
- Leading the review process for all CMC documents, consolidating all comments
- Driving the completion and on-time CMC approval of all CMC documents to submission-ready standards

Required Skills

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A University degree in Chemistry, Pharmacy or related natural science degree
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Experience using document management systems, e.g. CARA or Veeva Vault
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Good understanding of the pharmaceutical industry and the drug development process
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Excellent written and spoken English
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Experience of leading teams
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Experience of regulatory affairs

Desired Experience

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Experience of managing delivery teams and CMC regulatory documentation in a pharmaceutical company
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Experience of medical devices, combination products, inhaled products or new modalities

To be successful in this role we believe that you have a can-do attitude and an ability to set and manage priorities, resources and project initiatives.

About AstraZeneca Gothenburg Hub
Our stunning campus in Gothenburg is one of AstraZeneca's three strategic science centers. The site is home to over 2,500 employees, from 50 different nationalities. Gothenburg includes the complete range of functions, and as such offers plenty of development opportunities for a wide range of professionals. Our science teams in Gothenburg collaborate with academic and industry partners in Sweden and globally. And the site itself has been designed with collaboration in mind. From the Coffee Lab to exercise areas, we've built a series of environments where innovation can happen.

What's next!
If this sounds like the next challenge for you - apply today!
We look forward to your application no later than September 4, 2022.