Leslie Carter
Vice President, Global Regulatory Affairs at AbbVie
- Role
- Vice President, Global Regulatory Affairs at AbbVie
- Location
- North Chicago, IL, US
- LinkedIn followers
- 500 followers
About Leslie Carter
Highly skilled regulatory professional with more than 20 years of regulatory affairs and drug evelopment experience•Broad experience with regulatory strategy development, implementation, contingency planning•Strong communications and negotiation skills; management experience across broad range of skill sets•Global Regulatory Affairs experience•Drug life cycle regulatory and development experience – candidate selection through product retirement•Pharmacy background has allowed for successful support of multiple therapeutic areas including immunology, oncology, cardiovascular, anti-infectives, women’s health (hormonal and bone health therapies), epilepsy, allergy, asthma, neuroscience, gastrointestinal •Experience also includes personnel supervision; budgeting experience; CMC manufacturing and regulatory support; core and US labeling development and maintenance; computer system development and validation; early and late phase clinical development; third party organization partnerships and management; due diligence and L&A activities; SOP and quality system development, maintenance
Experience
Vice President, Global Regulatory Affairs
Apr 2016 — Present · North Chicago, IL, US
VP, Global Regulatory Strategy, Oncology, 2022-Present. Neuroscience, General Medicine and Eye Care Products, 20••••22. Supervise team of Global Regulatory Leads who are responsible for developing and implementing product global regulatory strategy. We do this by leading labeling and regulatory strategy product teams and global regulatory product teams for NCEs and combination products. My team also includes the US & C Leads who develop and implement the regulatory strategy in North America for the product portfolio. I provide regulatory strategic leadership on cross-functional therapeutic leadership teams to develop and implement TA strategy.
Education
The University of North Carolina at Chapel Hill
PharmD, Pharmacy
Butler University
BS, Pharmacy
Skills
- Pharmaceutics
- Clinical Operations
- Regulations
- Ind
- Cmc
- Drug Development
- Biopharmaceuticals
- Pharmaceutical Industry
- Fda
- Regulatory Affairs
- Clinical Development
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