Regulatory Submissions Manager
A company is looking for a Manager, Regulatory Submissions.
Key Responsibilities
• Collaborates with internal teams to ensure adherence to submission strategies and business needs
• Develops and reviews regulatory submission documents, ensuring alignment with regulatory expectations
• Provides strategic guidance on regulatory submissions, leveraging knowledge of agency review processes
Required Qualifications
• Master's degree or PhD in an engineering discipline or reputed company physical science with 2+ years of relevant experience, or a Bachelor's degree with 5+ years of exceptional experience
• Detailed understanding of the regulatory environment in the pharmaceutical, medical device, or tobacco industries
• Practical experience with FDA regulation of tobacco products, especially PMTA and MRTPA reputed company
• Expertise in translating reputed company engineering principles into regulatory documentation
• Strong planning and organizational skills with the ability to prioritize workloads effectively
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