Clinical Regulatory Associate
The role of a Clinical Regulatory Associate is crucial in ensuring the safe and effective delivery of products to patients. This position requires strong regulatory knowledge, strategic thinking, and excellent communication skills.
Key Responsibilities:
* Regulatory Strategy Development: Develop comprehensive regulatory strategies by leveraging scientific knowledge from FDA/Health Canada meetings and regulatory trends.
* Regulator Expectations Review: Review and summarize regulator expectations by utilizing agency feedback received and competitor labelling knowledge.
* Competitive Program Monitoring: Monitor upcoming and recent approvals of competitive programs.
* Strategic Communication: Communicate key information to enable seamless execution of US/Canada regulatory strategy.
* Regulatory Options Analysis: Analyze regulatory options and their impact on proposed product development plans, seeking alignment with Regulatory Scientist and management.
* Innovative Regulatory Strategies: Leverage innovative regulatory strategies with required data to accelerate asset development while enabling market differentiation.
* Labelling Document Development: Support strategic development of US/CA labelling documents for initial submission, line extensions, and key updates.
* Regulatory Discussions: Confirm, challenge, influence, and communicate strategic discussions based on industry precedent and new developments.
* Submission and Approval Requirements: Determine and communicate submission and approval requirements and regulator expectations.
* Regulatory Document Generation: Assist in generating regulatory documents for submissions.
* Regulatory Issue Resolution: Propose innovative solutions to regulatory and labelling issues to meet business objectives while maintaining compliance with applicable regulations and internal quality systems.
* Regulatory Advice: Provide high-quality, timely, and decisive regulatory advice that enables business partners to make well-informed decisions.
* Regulatory Risk Management: Communicate regulatory risks, potential impact, and mitigation plans with development team leadership and regulatory management.
* Communication and Collaboration: Execute high-quality communications with FDA, Health Canada, and internal customers to articulate and ensure understanding of the regulatory strategy.
Requirements:
* Bachelor's degree in a scientific or health sciences discipline.
* PREFERRED: 2 years' experience in regulatory affairs and/or drug development.
* Awareness of FDA and Health Canada procedures and practices across Review Divisions desirable.
* Deep knowledge of the drug development process, regulatory/business strategies, and plans required.
* Ability to assess and manage risk in a highly regulated environment.
* Strong written, spoken, and presentation communication skills.
* Negotiation and influence skills.
* Attention to detail.
* Effective teamwork skills; able to adapt to diverse interpersonal settings.