CMC Regulatory Affairs Director Biologics Location - Barcelona Competitive salary and benefits package Introduction to role: Join our Chemistry, Manufacturing, and Controls (CMC) Regulatory Affairs team in Barcelona, Spain, where we deliver expert CMC regulatory input for projects across the product lifecycle. As a CMC Regulatory Affairs Director, you will support the biologics technical area, encompassing both traditional and novel molecules. You will be a core member of our cross-functional Regulatory Strategy, Pharmaceutical and Global Supply Teams, collaborating with colleagues across the globe to ensure successful regulatory outcomes for clinical trials, marketing applications and complex post approval changes.
Accountabilities: In this role, 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. You will provide strategic, tactical and operational expertise to AstraZeneca project teams, handle high level risk by making sophisticated judgments, and develop innovative solutions. You will lead project driven regulatory interactions with health authorities, such as FDA and EMA, for CMC scientific advice. You will also be asked to support due diligence reviews.
Essential Skills/Experience: - Bachelor's degree or equivalent experience 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.
Desirable Skills/Experience - Advanced degree or equivalent experience 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
When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
At AstraZeneca's Biopharmaceuticals R&D division, we follow the science to explore and innovate. We are working towards treating, preventing, modifying and even curing some of the world's most complex diseases. Here we have the potential to grow our pipeline and positively impact the lives of billions of patients around the world. We are committed to making a difference by fusing data and technology with the latest scientific innovations to achieve the next wave of breakthroughs. We are driven by our desire to understand and reveal new insights. We are free from fear of failure, free to ask the right questions, make bold decisions, and dig deep into the biology of complex disease.
Ready to make a meaningful impact on patients' lives? Apply now and strengthen our pipeline to help more patients and grow our area.
We encourage your application by the 11th June 2024.
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