CMC REGULATORY AFFAIRS ASSOCIATE DIRECTOR

Location.
Barcelona, Spain (we requiere 3 days working from the office and 2 days working from home 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 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 Associate Director to add to our dynamic team in our Barcelona, Spain hub.
This role will support the biologics technical area, encompassing both traditional and novel molecules.
CMC Regulatory Affairs Associate Directors are a core member of our cross-functional Regulatory Strategy, Pharmaceutical and Global Supply Teams.
Working in partnership with the technical functions, CMC Associate Directors collaborate with colleagues in AZ marketing companies 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 Associate 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.
.
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.
You may also be asked to support due diligence reviews.
Minimum Qualifications.
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 biologics drug substances and products.
Desired Qualifications.
Advanced degree in a science or technical field such as pharmacy, biology, chemistry, or biological science Regulatory Affairs CMC experience with submissions for antibody drug conjugates, radioconjugates or bispecifics 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.