Regulatory Affairs Leader
hace 1 semana
This position is responsible for managing all facets of regulatory support to market innovative medical solutions. The Associate Director will contribute to the development of the Regulatory Affairs strategy, overseeing labeling, package inserts, promotional materials, and product changes for regulatory compliance.
The role involves directing regulatory submissions, including dossier development and electronic publication, ensuring compliance and timely approvals. Additionally, the Associate Director will provide regulatory direction to project teams, defining strategies for new products and communicating them to the RA group.
Beyond technical expertise, the successful candidate will possess strong communication and negotiation skills, effectively engaging with Regulatory agencies, management, and cross-functional teams. Experience in team management, fostering collaboration and professional growth, is also essential.
Key Responsibilities:- Direct regulatory submissions, including dossier development and electronic publication
- Provide regulatory direction to project teams, defining strategies for new products
- Oversee labeling, package inserts, promotional materials, and product changes for regulatory compliance
- Interpret and apply regulations to business practices, offering strategic guidance to the organization
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Compliance and Regulatory Affairs Expert
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