Manager / Senior Manager, Regulatory Affairs
Klein Hersh - Berkeley Heights, NJ
Apply NowJob Description
Our client develops and markets high-quality and cost-effective generic drugs in the United States.The Regulatory Affairs Manager/Senior Manager will be responsible for independently compiling and maintaining compliant US drug product applications throughout the product lifecycle, from initial development to product termination, ensuring on-time completion of regulatory milestone activities in support of project timelines and commercial business needs. He/She should be able to interpret and communicate regulatory requirements and strategies with minimal supervision to internal and external functional business units. The Regulatory Affairs Manager/Senior Manager is a self-motivated, detail-oriented, flexible team player who is able to multi-task and work independently with minimal supervision.Key ResponsibilitiesCompile high quality and right-first-time submissions (Abbreviated New Drug Applications/New Drug Applications, amendments, supplements, annual reports, etc.) for sterile products.Author ANDA/NDA modules for original applications, amendments, supplements, etc., for submission to FDA.Maintain full awareness of all regulatory activities on assigned projects and ensure project deadlines and performance standards are met.Work with internal and external stakeholders to manage submission schedules.Represent regulatory affairs in project team meetings and provide regulatory guidance to team members.Prepare controlled correspondences and meeting packages related to pre- and post-ANDA/IND/NDA meetings with the FDA.Review technical reports, summary documents, and evaluate change controls for appropriate content.Formulate strategies with minimal guidance to ensure proper filing categories in accordance with FDA requirements.Point-of-contact with FDA for the exchange of information as required.Assess and stay current with new and changing FDA guidances/regulations.Train and provide guidance to junior department members.Actively participate in/support Due Diligence project activities for complex products.Identify the need and implement improvements to existing department procedures and processes or SOPs where applicable.Key RequirementsBachelor's degree required in a scientific discipline such as Chemistry, Biology, or Pharmacy. Graduate degree preferred.More than 8 years of experience in the pharmaceutical industry.A minimum of 6 years of experience in drug regulatory affairs.A minimum of 3 years of regulatory experience in sterile products.Experience with inhalation or transdermal dosage forms is a plus.Excellent attention to detail and organizational skills.Strong analytical and problem-solving abilities.Effective communication and interpersonal skills.Ability to work both independently and collaboratively in a team environment.
Created: 2024-10-01