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In an environment where medical product regulations seem to be expanding continuously, proportional investment in compliance infrastructure and controls runs the risk of diminishing returns. The key to achieving the right balance of commercial success and compliance is to focus on continuous improvement, specifically root-cause analysis.
The US Food and Drug Administration (FDA) has published a new draft guidance intended to assist industry with developing products under the agency's so-called "Animal Rule," a regulatory pathway intended to facilitate approvals of medical countermeasures to rare, emerging or serious pathogens.
Raland Compliance Partners is a full-service life sciences consulting firm providing compliance consultation and guidance for organizations in the pharmaceutical, biotech and medical device industries. Raland strives for immediate and sustained process improvement, from product development to patient delivery.
We are looking for a dynamic regulatory professional to independently review and prepare regulatory submissions, execute regulatory strategy, assist senior RA leaders with the facilitation of approval of regulatory submissions, coordinate appropriate responses to the FDA, provide regulatory training, and manage the preparation for FDA meetings and assist with strategic guidance. This position is based in Florida.
BS in a scientific discipline or equivalent experience, MS preferred.
Five to seven years of regulatory affairs experience in the pharmaceutical and / or medical device industries.
Electronic CTD submissions experience a plus.
Knowledge of project management with the ability to manage multiple projects.
Ability to create, correct and coordinate required documentation for regulatory submissions.
Strong understanding of regulations governing manufacture of drug products for human use, especially understanding of the container closure systems.
Solid knowledge of global regulatory requirements.
Excellent written and verbal communication skills.
Detailed oriented with strong organizational skills with the ability to prioritize and multitask.
Excellent time management skills.
Ability to work independently and in a dynamic team environment.
Ability to travel up to 20% mostly in the U.S. to client's contract manufacturing facilities.