CMC Regulatory Affairs Associate DirectorLocation: Barcelona, Spain (we require 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.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 the 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 scienceBreadth of knowledge of manufacturing, project, technical, and regulatory project managementStrong understanding of regulatory affairs globally, particularly with respect to the CMC fieldRegulatory 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 scienceRegulatory Affairs CMC experience with submissions for antibody drug conjugates, radioconjugates, or bispecifics
#J-18808-Ljbffr
