Associate Director, Regulatory Affairs (Remote)

Role Summary

Associate Director, Regulatory Affairs (Remote) responsible for leading regulatory strategies and interactions to obtain worldwide approvals for Jazz Pharmaceuticals’ products, and contributing to project teams evaluating product concepts.

Responsibilities

• Develop and implement regulatory strategies to facilitate progress of programs in all development phases
• Serve as the Regulatory Affairs representative on project teams; provide direction, solutions, and feedback to teams
• Lead regulatory interactions with health authorities, marketing partners, and vendors
• Support commercial products
• Review and approve labeling for products
• Ensure timely submission of INDs, NDAs, amendments, and supplements
• Monitor regulatory requirements and provide training and regulatory intelligence to the organization

Qualifications

• Required: A minimum of 8 years in regulatory affairs or related areas in pharmaceutical drug development
• Required: Deep and broad knowledge of regulatory affairs; direct experience with regulatory submissions and product approvals
• Required: Proven ability to collaborate with regulatory agencies (FDA, EMA, PMDA)
• Required: Demonstrated leadership in management of regulatory activities
• Required: Excellent verbal and written communication skills
• Required: Evaluative, analytical, and interpretative skills for regulatory planning and submissions
• Required: Ability to work with limited supervision, set priorities, meet timelines, and influence others

Education

• Masters or advanced degree in a scientific discipline preferred

Additional Requirements

• Equal opportunity employer information omitted as per policy; travel or physical requirements not specified as essential