CMC Regulatory Affairs Director
Location: Cheshire East, County Dublin, Gaithersburg, Maryland
Job Type: Full time
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.
Here at AstraZeneca, we are looking to enable you to be the best you can be. We thrive in our inclusive and ambitious environment. We draw on our knowledge to take thoughtful risks and uncover creative ways to better deliver for our patients and our business.
Our Chemistry, Manufacturing, and Controls (CMC) Regulatory Affairs function delivers expert CMC regulatory input for projects spanning across the product lifecycle and leads the regulatory strategy for the development, manufacturing and testing of all of our medicines. With our expertise we interpret, anticipate and craft global Health Authority expectations to build CMC and Device Regulatory Strategies.
We are seeking a CMC Regulatory Affairs Director to add to our hard-working team in either our Gaithersburg (MD), US; Macclesfield, UK; Mississauga (ON), Canada; or Dublin, Ireland hubs. This role will support the biologics technical area, encompassing both traditional and novel molecules.
CMC Regulatory Affairs Directors are core members of our cross-functional Regulatory Strategy, Pharmaceutical Development, and Global Supply Teams. Working in partnership with the technical functions, CMC RA Directors collaborate with colleagues in AZ locations across the globe to ensure successful regulatory outcomes for clinical trials, marketing applications and complex post-approval changes to meet the needs of our patients and the business. We pride ourselves on our encouraging culture and cross-project knowledge sharing.
As a CMC Regulatory Affairs Director you will:
- Use your regulatory experience to devise creative strategies to support a range of new biological entities and novel products, from development to post-approval lifecycle management.
- Provide strategic, tactical and operational expertise and direction to AstraZeneca project teams, based on understanding of global CMC regulations;
- Handle high level risk by making sophisticated judgments, developing innovative solutions and applying comprehensive cross-functional and industry understanding;
- Have a high level of interactive social skills and cultural sensitivity which you will use to advise CMC teams on how to achieve successful regulatory outcomes;
- Lead project driven regulatory interactions with health authorities, e.g. FDA, EMA, for CMC scientific advice;
- Lead and/or deliver CMC Regulatory components of business process improvement projects.
- Ensure the application of global CMC regulations and guidance within AstraZeneca and lead development of new guidance
- Share your knowledge actively within CMC RA and the wider business, participate in the coaching and mentoring of colleagues and keep up to date with emerging global regulatory requirements;
- Represent AstraZeneca in cross-industry forums and working groups to advocate for regulatory positions in alignment with our innovative scientific approaches
- You may also be asked to support due diligence reviews.
- Bachelor’s degree in a science or technical field such as pharmacy, biology, chemistry or biological science
- Breadth of knowledge of manufacturing, project, technical and regulatory project management;
- Strong understanding of regulatory affairs globally, particularly with respect to the CMC field;
- Regulatory Affairs CMC experience with submissions for biologic drug substances and products.
- Advanced degree in a science or technical field such as pharmacy, biology, chemistry or biological science
The position can sit at our Macclesfield, UK; Gaithersburg US; Mississauga Canada, or Dublin, Ireland locations
Competitive benefits and salary.
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. Interested? Come and join our journey.
So, what’s next!
- Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available, and we hope it’s yours.
Where can I find out more?
Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/
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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 (e.g. race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status). We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.
AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.