Do you have experience of, and passion for, Regulatory Affairs (CMC)? Would you like to apply your knowledge to impact the introduction of new products globally in a company that follows the science and turns ideas into life-changing medicines? Then you’re the one we’re looking for!

Operations Regulatory is a global function that manages all Chemistry, Manufacturing and Controls (CMC) post-approval regulatory activities across AstraZeneca’s global supply chain. In our organization, the New Product Introduction (NPI) team effectively manage projects or complex product ranges in order to deliver the needs of both the AZ business and the customer. This includes contributing to and leading Regulatory CMC components of global business related projects.

Our team is committed to influence and accelerate our Regulatory CMC submissions through innovative ways and partnering across the business to expedite medicines to patients. We generate innovative regulatory product strategies, collaborating within the CMC community and taking smart risks to secure manufacturability, launch and supply of new products to support our patients.

What you’ll do

As a Regulatory CMC Manager in the NPI team you will ensure that Chemistry, Manufacturing and Control (CMC) documentation for designated new and newly marketed products is produced in the required format and to the agreed timetable.

You will make sure that key stakeholders across Global Regulatory Affairs and Operations are kept informed of relevant timelines and regulatory commitments for those products. You will be a partner within relevant product or project teams providing regulatory intelligence and advice, and strategic input, as appropriate. Part of the role is also to project manage timely submission of NPI CMC documentation and coordinate assembly documentation of submission-ready components to support NPI submissions. This along with reviewing and approving regulatory CMC documents on behalf of Operations Regulatory.

Further, the role consist of:

• Provide CMC Regulatory advice on submission strategy and tactics for execution of submissions for new and newly marketed products
• Work in partnership with global partners across AZ, Global Regulatory Affairs, Pharmaceutical, Technology and Development, Marketing Companies and Operations
• Provide Regulatory Intelligence to support the operational and tactical regulatory CMC contribution and direction to AstraZeneca product and project teams in support of drug products throughout the life cycle
• Ensure that all relevant electronic systems are updated and maintained in alignment with regulatory submissions and ensure manufacturing sites are notified of health authority approvals
• Ensure that lessons learnt from own projects are shared with other colleagues / within the department and relevant project/product teams
• Alongside other team members supervise development products progress throughout the portfolio from Phase 2A onwards and be responsible for providing advice relating to post approval regulatory strategies and international marketing submission planning in preparation for MAA work

Essential for the role

We would like you to hold a degree in a scientific subject area (e.g. chemistry, pharmacy or biological science).

In addition to this you need:

• Experience from working in the Pharmaceutical industry (Regulatory Affairs or Pharmaceutical Production or Quality Assurance or R&D) or within Pharmaceutical Agencies or Associations
• Experience of working with or contributing to Regulatory CMC submissions
• Excellent written and spoken English

Desirable for the role

• Knowledge of the drug development process and regulatory submissions
• Understanding of current Regulatory CMC requirements
• Experience of international rollouts of marketing authorizations and license to operate activities
• Project management skills

Why AstraZeneca?

At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognising their potential. Join us on our journey of building a new kind of organisation to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, pioneering cutting edge methods and bringing unexpected teams together.

Are you already imagining yourself joining our team? Great, we can’t wait to hear from you!

Please submit your application in English, no later than September 15th.

If you’re curious to know more, then please contact Ylva Hedberg: ylva.hedberg@astrazeneca.com, Karin Grosch: karin.grosch@astrazeneca.com or Angela Currie: angela.currie@astrazeneca.com.

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.