What are the responsibilities and job description for the Regulatory Affairs - Submissions position at Planet Pharma?
Complete cover letters, FDA Form 1571 and other documentation for submission to FDA as needed.
Coordinate between regulatory affairs and the regulatory submissions group
Perform Quality Control reviews of regulatory submissions.
Assist with creating and logging meeting minutes
Assist with study start up and maintenance activities relevant to regulatory affairs, as needed
Assist with project management activities for large regulatory submissions
Assist with Trial Master File activities
Support larger submissions, such as INDs and NDAs, including organizing the submission review process, preparing sections, reviewing for completeness, accuracy, and appropriateness, and formatting for submission.
Offer guidance to project teams with regard to regulatory issues.
Bachelor’s degree in Science (e.g. Chemistry, Pharmacy, Biochemistry) preferred.
Minimum of 2 years of Pharmaceutical industry experience in Regulatory Affairs Strategy.
Working knowledge and experience in regulatory submissions and product life cycle management.
Knowledge of drug regulations and guidance with ability to apply to regulatory issues and requirements.
Ability to coordinate and monitor activities on multiple projects.
Ability to self-direct workload, including reprioritizing and delivery under tight timelines.
Detail-oriented team player capable of multitasking and prioritizing.
Adaptable to changing priorities.
Proficient in the use of common Microsoft software programs.
Ability to analyze and communicate scientific information from a broad range of disciplines.
Excellent writing, editing, verbal, and interpersonal communication skills, and strong attention to detail.
Familiarity with CTD, ICH, GCP, and other standards.
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