Clinical Regulatory Associate
Our client, a global pharmaceutical company, is recruiting for a Clinical Regulatory Associate to join their global regulatory team on a permanent basis. As a Clinical Regulatory Associate, you will be accountable for the US and Canada regulatory strategies that support the expedited delivery of safe and effective products to patients.
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Responsibilities:
* Assist the Regulatory Scientist in developing regulatory strategy by leveraging scientific knowledge from FDA/Health Canada meetings and regulatory trends.
* Review and summarize information regarding regulator expectations by utilizing agency feedback received and knowledge of competitor labeling.
* Monitor upcoming and recent approvals of competitive programs.
* Communicate key information to enable seamless execution of US/Canada regulatory strategy.
* Communicate regulatory options and impact on proposed product development plans, seeking Regulatory Scientist and management alignment.
* Leverage innovative regulatory strategies with accompanying required data to accelerate asset development while enabling market differentiation.
* Support strategic development of US/CA labeling documents for initial submission, line extensions, key MOH-initiated changes, and key PMR-related updates, and provide responses to agency labeling questions in collaboration with Regulatory Scientist.
* Confirm, challenge, influence, and communicate strategic discussions based on industry precedent and new developments.
* Determine and communicate submission and approval requirements and regulator expectations.
* Assist Regulatory Scientist to generate regulatory documents for submissions.
* Propose innovative solutions to regulatory and labeling issues to meet business objectives while maintaining compliance with applicable regulations and internal quality systems.
* Provide high-quality, timely, and decisive regulatory advice, in collaboration with the Regulatory Scientist, that enables business partners to make well-informed decisions on development of drugs, diagnostics, devices, and product lifecycle planning and business development.
* Communicate regulatory risks, potential impact, and mitigation plans with development team leadership and regulatory management.
* Execute high-quality communications with FDA, Health Canada, and internal customers to articulate and ensure understanding of the regulatory strategy in partnership with Regulatory Scientist.
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Requirements:
* Bachelor's degree in a scientific or health sciences discipline.
* PREFERRED: Industry-related experience in regulatory affairs and/or drug development experience for 2 years.
* Knowledge of FDA and Health Canada procedures and practices across Review Divisions and awareness of evolving regulatory reform initiatives desirable.
* Demonstrated deep knowledge of the drug development process, regulatory/business strategies, and plans required.
* Demonstrated ability to assess and manage risk in a highly regulated environment.
* Demonstrated strong written, spoken, and presentation communication.
* Demonstrated negotiation and influence skills.
* Demonstrated attention to detail.
* Demonstrated effective teamwork skills; able to adapt to diverse interpersonal settings.