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Associate Director, Global Regulatory Affairs CMC
hace 4 semanas
This is a key leadership role in our Global Regulatory Affairs team, responsible for providing strategic guidance and oversight on CMC regulatory matters for our clinical and commercial product portfolio.
Key Responsibilities- Provide CMC regulatory support and advice for all internal activities related to manufacturing, development, control, and quality of commercial and clinical products.
- Lead and manage assigned CMC programs, including Life Cycle Teams and compliance of clinical and commercial products.
- Develop and prepare high-quality regulatory submissions, including CMC dossiers, supplements, and renewals.
- Define and lead the development of proactive regulatory strategies for global CMC product lifecycle management.
- Manage and track global regulatory CMC commitments, and ensure accountability to regulatory authorities.
- Investigate opportunities for regulatory innovation and promote the use of novel approaches.
- Prepare teams for pre-submission meetings with regulatory authorities and interface directly with Health Authorities.
- Relevant technical experience in biopharmaceutical or related industry experience with at least 6 years of Regulatory CMC experience.
- Extensive experience in CMC of antibodies, protein therapeutics, or other biological products.
- Strong written and oral communication skills, with ability to build relationships with numerous stakeholders.
- Broad functional knowledge of pharmaceutical sciences and the Biopharmaceutical industry.
AstraZeneca is an equal opportunities employer and welcomes applications from all qualified candidates. 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.
