Regulatory Lead: EU Centralized Procedures Expert

Syneos Health, Inc.; United States; On-site; USD 90,000 - 130,000; Full time

Job summary

Syneos Health is seeking a Regulatory Consultant with EU Centralized Regulatory Procedure experience for an office-based role in the United States. The candidate will lead regulatory strategy and lifecycle activities, work with cross-functional teams, and manage regulatory submissions for global products.

Minimum 4–5 years in Regulatory Affairs with an M.Pharm degree is required. Fluent English and strong client-facing skills are essential to success in this role.

Qualifications

• Regulatory submissions experience (IND, PMA, NDA, MAA, CTD) including electronic submissions.
• 2) Excellent interpersonal and written/verbal communication skills.
• 3) Proficiency in Microsoft Office applications.

Responsibilities

• Research regulatory requirements for global/regional submissions and prepare gap analyses.
• Prepare regulatory submissions for INDs, pre-approval packages, registrations, and post-approval maintenance.
• Oversee day-to-day regulatory activities per timelines, budgets, and strategies.
• Participate on cross-functional project teams to develop products through lifecycle.
• Act as SME and provide solutions to project-related problems.
• Prepare estimates for regulatory services and support client meetings.

Skills

Regulatory Affairs

M.Pharm

Regulatory Lead

Regulatory strategy

Lifecycle management

Client-facing

Independent initiative

Education

M.Pharm

Tools

MS Office

Job description

Syneos Health is seeking a Regulatory Consultant with EU Centralized Regulatory Procedure experience for an office-based role in the United States. The candidate will lead regulatory strategy and lifecycle activities, work with cross-functional teams, and manage regulatory submissions for global products.

Minimum 4–5 years in Regulatory Affairs with an M.Pharm degree is required. Fluent English and strong client-facing skills are essential to success in this role.