Posted 4726 days ago
Perrigo is seeking a Regulatory Affairs Project Manager. This is a full-time job in Allegan, Mich.
Job Description
The person who is hired for this job will:
• Assemble and review data and information required for ANDA and NDA submissions and amendments for new drug products.
• Work closely with all relevant departments to ensure availability of proper documents for timely filing of approvable submissions.
• Communicate with FDA to resolve issues and ensure expeditious approvals and relay information to appropriate groups within company.
• Assemble and file supplements for ANDAs and NDAs and Annual Reports. Review bioequivalence and clinical study protocols and coordinating studies with CROs.
• Implement post-approval activities including labeling and trade dress supplements.
• Lead or participate in task force activities related to supplements and new applications. Participate in formulation of submissions and approval strategies for projects.
Required Skills
Masters degree in Chemistry, Microbiology, or Pharmaceutical Science and three years experience as Regulatory Affairs Project Manager, Regulatory Affairs Specialist, Regulatory Affairs Associate or related in the pharmaceutical industry or Bachelor's degree in Chemistry, Microbiology, or Pharmaceutical Science and five years progressively responsible experience as Regulatory Affairs Project Manager, Regulatory Affairs Specialist, Regulatory Affairs Associate or related in the pharmaceutical industry required.
Perrigo is an Equal Opportunity Employer.