Opportunity Description
Our Client, an American Biotechnology company, is looking for a Regulatory Affairs Specialist 4 for their Sunnyvale, CA/Hybrid location. Responsibilities:
+ Provide regulatory guidance to product teams, develop regulatory plans, and review and approve product design control documentation.
+ Determine regulatory pathways and formulate regulatory strategies for the U.S. and Canadian markets.
+ Assess regulatory impact on design, materials, labeling, packaging, manufacturing processes, and facility changes. Influence and lead global regulatory strategies.
+ Coordinate with technical experts to provide additional data/information requested by regulatory agencies and prepare responses to facilitate regulatory approvals.
+ Provide risk-based guidance and regulatory input to projects and issues, ensuring cross- functional alignment and resolution.
+ Collaborate with international counterparts to support global regulatory submiss...
+ Provide regulatory guidance to product teams, develop regulatory plans, and review and approve product design control documentation.
+ Determine regulatory pathways and formulate regulatory strategies for the U.S. and Canadian markets.
+ Assess regulatory impact on design, materials, labeling, packaging, manufacturing processes, and facility changes. Influence and lead global regulatory strategies.
+ Coordinate with technical experts to provide additional data/information requested by regulatory agencies and prepare responses to facilitate regulatory approvals.
+ Provide risk-based guidance and regulatory input to projects and issues, ensuring cross- functional alignment and resolution.
+ Collaborate with international counterparts to support global regulatory submiss...
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