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Clinical Regulatory Associate
Our client, a global pharma company, is currently 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.
Responsibilities:
1. Assist the Regulatory Scientist in developing regulatory strategies by leveraging scientific, drug/device clinical development knowledge, and insights from FDA/Health Canada meetings and regulatory trends.
2. Review and summarize information regarding regulator expectations, utilizing agency feedback and knowledge of competitor labeling.
3. Monitor upcoming and recent approvals of competitive programs.
4. Communicate and share key information to enable seamless execution of US/Canada regulatory strategies.
5. Communicate regulatory options and impacts on proposed product development plans, seeking alignment with Regulatory Scientists and management.
6. Leverage innovative regulatory strategies with the necessary data to accelerate asset development and enable market differentiation.
7. Support the strategic development of US/Canada labeling documents for initial submissions, line extensions, MOH-initiated changes, and PMR-related updates; collaborate with Regulatory Scientists to respond to labeling questions, applying expertise and industry knowledge to influence commercially viable labeling.
8. Influence and communicate strategic discussions based on industry precedent and new developments.
9. Determine and communicate submission and approval requirements, and regulator expectations.
10. Assist Regulatory Scientists in generating regulatory documents for submissions.
11. Propose innovative solutions to regulatory and labeling issues to meet business objectives while maintaining compliance.
12. Provide high-quality, timely regulatory advice to enable informed decision-making on drug development, diagnostics, devices, and product lifecycle planning.
13. Communicate regulatory risks, impacts, and mitigation strategies with development teams and management.
14. Execute high-quality communications with FDA, Health Canada, and internal stakeholders to articulate and ensure understanding of regulatory strategies in partnership with Regulatory Scientists.
Requirements:
* Bachelor’s degree in a scientific or health sciences discipline.
* Preferred industry-related experience in regulatory affairs and/or drug development for at least 2 years.
* Knowledge of FDA and Health Canada procedures, practices, and evolving regulatory initiatives.
* Deep understanding of the drug development process, regulatory strategies, and plans.
* Ability to assess and manage risks in a highly regulated environment.
* Strong written, spoken, and presentation communication skills.
* Negotiation and influence skills.
* Attention to detail.
* Effective teamwork skills; adaptability to diverse interpersonal situations.
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