Teva Manager Regulatory Affairs 

United States, New Jersey 

743243007

• Requires a Bachelor’s degree in Pharmacy Administration, Pharmaceutical Science, Regulatory Affairs, or a related field, and 3 years of Regulatory Affairs experience.
• Must have 2 years of sterile/ parenteral dosage form experience (such as different forms of injections, ophthalmics, or otics).

Must have experience with:

• Chemistry, Manufacturing and Controls (CMC) in drug development process.
• Quality Target Product Profile and Critical Quality Attributes, drug composition, product and process design, various specification settings, analytical methods, analytical method validation, sterility assurance, manufacturing, stability design and stability data analysis during drug development and life cycle of drugs.
• Change controls and regulatory assessment of change controls.
• Software to assess change controls such as TrackWise;
• FDA/ICH regulations pertaining to Generic Drug User Fee Act (GDUFA)/ Prescription User Fee ACT (PDUFA), CMC and regulatory filing aspects; Drafting correspondences to FDA.
• Software (such as Liquent/ Docubridge/ eCTD Express) used in Regulatory Operations; and MS Word, MS Excel, Adobe Pro and using internet to browse FDA websites and other FDA information repositories (IIG database, Orange Book, Drug Approval Database, Dailymed, Product Specific Guidance database).

THIS POSITION IS ELIGIBLE FOR THE EMPLOYEE REFERRAL PROGRAM.

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