Are you as passionate about Regulatory affairs as we are?

Do you have expertise in, and passion for, Regulatory CMC? Would you like to apply your expertise to impact the introduction of new products globally? in a company that follows the science and turns ideas into life-changing medicines? Then AstraZeneca might be the one for you!


At AstraZeneca we turn ideas into life-changing medicines and strive to continuously meet the unmet needs of patients 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.


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 strategies 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.


More specifically, we are a small specialist team working closely together, organized within Global Operations sat in the Operations Regulatory team. Today, we are 3 colleagues in Södertälje, 4 in Macclesfield, and we're all looking forward to meeting our new colleague!

Within our organization, we call this role Regulatory Account Manager, but maybe you've had the title Regulatory Affairs manager, CMC Regulatory Lead Project Manager or Regulatory Affairs Associate Director.


What you'll do


As our Regulatory Account Manager you will provide operational, tactical and strategic regulatory CMC expertise and direction to AstraZeneca product and project teams in support of drug products throughout their life cycle, which will include proactively sharing any new regulatory intelligence.


You will define the content of CMC submissions and review and approve regulatory CMC documents on behalf of Operations Regulatory for assigned projects or products as appropriate.


You'll do this by anticipating and proactively manage risk through evaluative judgements in complicated or novel situations. You will ensure the application of global CMC regulations and guidance within AstraZeneca and also contribute to the development of new guidance, policy and processes. You will be skilled in all levels of interactive communication with stakeholders and project team members and be proficient indirectly advising and influencing where required.


You will be required to contribute and provide leadership in the management of changes and establish effective networks with Global Regulatory Affairs, manufacturing sites and relevant technical functions.


You will provide AZ technical functions with clear, concise guidance on current CMC regulatory requirements to support business tactical or strategic planning and provide expert recommendations and decisions on regulatory issues relating to CMC for individual products or portfolios of products, including proactive risk management and mitigation.


Essential for the role:

* Experienced graduate or PhD in a scientific field, typically chemistry, pharmacy or a biological science (equivalent experience will be considered)
* In depth understanding of current CMC regulatory requirements
* Excellent written and spoken English
* Influencing
* Project Management

To thrive in this role from day one you need to have in-depth knowledge of the drug development process inclusive of the regulatory processes. Turning your attention inwards you need to be a natural self-starter, open to and creating new ideas and solutions.


Nice to have for the role:

* Experience of working with international rollouts of marketing authorizations and license to operate activities.
* Experience of regulatory authority interactions and/or advocacy


Are you ready to make a difference? Send in your application, and we'll make it happen together. You're just a click away.


If you're curious to know more, then please contact Ylva Hedberg ylva.hedberg@astrazeneca.com or Angela Currie : angela.currie@astrazeneca.com. Welcome with your application, no later than March 22nd.