New Jersey Licensed Regulatory Consultant

Job Summary

Leading end-to-end planning and coordination for US regulatory label change activities, the full-time onsite New Jersey Licensed Regulatory Consultant will manage complex regulatory timelines, liaise with cross-functional teams, and ensure alignment across organizations in a fast-paced integration environment.

Key Responsibilities

• Serve as the internal PM for the Regulatory Workstream, owning planning and coordination for US regulatory label change activities
• Evaluate and develop integrated regulatory timelines based on historical data, iterating as new information arises
• Partner with external regulatory counterparts to align business plans and filing sequencing across organizations

Required Qualifications

• Bachelor's degree in Life Sciences, Regulatory Affairs, Pharmacy, Chemistry, Biology, or a related discipline
• Seven or more years of experience in a regulated life sciences environment with demonstrated project management capability
• Regulatory domain familiarity, particularly with submissions and labeling requirements
• Experience in integration, transition, or M&A environments is strongly preferred
• PMP certification or equivalent project management credential preferred