Position has been filled
AbbVie Inc. logoAbbVie Inc. logo

Associate Director, Regulatory Affairs CMC

On-site Full-time
Position filled

Experience Level

Mid to Senior

Qualifications

To qualify for this position, candidates should have:A Master's degree in a relevant scientific discipline; a Ph. D. is preferred. At least 5 years of experience in regulatory affairs, specifically in CMC. Demonstrated knowledge of FDA and international regulatory submissions. Excellent communication skills and the ability to work collaboratively across teams. Strong analytical skills and attention to detail.

About the role

AbbVie is seeking an accomplished Associate Director in Regulatory Affairs CMC to lead and oversee regulatory strategies for our product portfolio. In this role, you will be responsible for the preparation and submission of regulatory documents, ensuring compliance with evolving regulations and guidelines.

You will collaborate with cross-functional teams, providing expertise in CMC (Chemistry, Manufacturing, and Controls) regulatory matters while driving initiatives that align with our company’s mission to advance patient care.

The ideal candidate will possess a strong background in regulatory affairs within the pharmaceutical or biotechnology industry, with proven experience in product submissions to regulatory authorities.

About AbbVie Inc.

AbbVie is a global biopharmaceutical company committed to discovering and delivering innovative medicines that address serious health issues. With a rich pipeline and a focus on areas like immunology, oncology, and neuroscience, we strive to create a remarkable impact on the lives of patients worldwide.

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