Clinical Regulatory Lead
4 days ago
Responsibilities:
- Develop and update US and Canada registration strategies, leveraging scientific, drug/device clinical development, and knowledge from FDA/HC meetings and regulatory trends.
- Review, summarize, and present information regarding regulator expectations by utilizing agency feedback received by the organization and knowledge of competitor labelling.
- Monitor upcoming and recent approvals of competitive development programs/plans.
- Integrate US/CA regulatory strategy into global registration strategy.
- Partner with colleagues across regulatory functions to deliver integrated US/Canada regulatory strategy.
Requirements:
Bachelor's degree in scientific or health sciences discipline.
Industry-related experience in regulatory affairs and/or drug development experience for minimum of 5-8 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 skills.
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