Pennsylvania Licensed Regulatory Manager
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
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
