Pennsylvania Licensed Regulatory Manager

Job Summary

A company is looking for a Regulatory Project Manager with a strong background in sterile injectables.

Key Responsibilities

• Lead and manage regulatory projects from initiation to completion, ensuring timelines and milestones are met
• Develop and implement regulatory strategies for a range of drug products, including sterile injectable products
• Prepare, review, and submit regulatory documents to global health authorities, ensuring compliance with applicable regulations

Required Qualifications

• Bachelor's or advanced degree in a related science discipline
• Minimum of 7+ years of experience in regulatory affairs within the pharmaceutical industry, focusing on sterile injectables
• Advanced knowledge of global regulatory requirements and guidelines
• Proven success in managing regulatory submissions and interactions with authorities
• Strong project management skills with the ability to prioritize tasks and manage multiple projects simultaneously