CMC Regulatory Affairs Associate Director
hace 4 semanas
Job Title: CMC Regulatory Affairs Associate Director
About the Role:
We are seeking a highly skilled CMC Regulatory Affairs Associate Director to join our dynamic team in Barcelona, Spain. As a key member of our cross-functional Regulatory Strategy, Pharmaceutical, and Global Supply Teams, you will collaborate with colleagues across the globe to ensure successful regulatory outcomes for clinical trials, marketing applications, and complex post-approval changes.
Key Responsibilities:
• Develop creative strategies to support new biological entities and novel products from development to post-approval lifecycle management.
• Provide strategic, tactical, and operational expertise to AstraZeneca project teams based on understanding of global CMC regulations.
• Lead high-level risk by making sophisticated judgments, developing innovative solutions, and applying comprehensive cross-functional and industry understanding.
• Lead project-driven regulatory interactions with health authorities, such as FDA and EMA, for CMC scientific advice.
• Ensure the application of global CMC regulations and guidance within AstraZeneca and lead the development of new guidance.
Requirements:
• 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.
What We Offer:
• A dynamic and encouraging culture with opportunities for cross-project knowledge sharing.
• A chance to work with a global team and contribute to the development of innovative medicines.
• A competitive salary and benefits package.
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