Clark Davis Associates · 2 days ago
Associate Director Regulatory Affairs (Global Submission)
Essex County, NJ
Full-time
Onsite
Senior Level, Lead/Staff, Director/Executive
7+ years expClark Davis Associates is seeking an Associate Director Regulatory Affairs (Global Submission) to lead the execution of global regulatory submissions. This role involves strategic oversight and operational leadership to ensure compliance with regulatory requirements and timely delivery of submissions.
Professional ServicesRecruitingStaffing Agency
Responsibilities
Serving as submission lead for global applications (e.g., INDs, NDAs, MAAs, amendments, and variations)
Coordinating cross-functional stakeholders
Managing resources and vendors
Maintaining the Global Submission Content Plan
Partnering closely with regional submission leads (EU and Asia)
Leveraging follow-the-sun processes to meet aggressive timelines while ensuring adherence to FDA, EMA, PMDA, ICH, CDISC, and emerging market standards
Qualification
Required
Bachelor's degree in scientific or information technology field; advanced degree preferred
7-10+ years of pharmaceutical industry regulatory experience
5-8+ years of experience with submissions management, process development, standards development and compilation of electronic major submissions required
Strong knowledge of U.S. and EU regulatory submission requirements, including Emerging Markets
Advanced experience across the drug development lifecycle and eCTD submission standards
Proven ability to develop and manage regulatory submission timelines for global health authority filings
Highly organized with the ability to manage multiple submissions in a fast-paced, deadline-driven environment
Demonstrated capability to work independently with minimal supervision while maintaining accuracy and accountability
Adaptable to change, with experience implementing process improvements to support organizational effectiveness
Clear and effective written and verbal communication skills
Hands-on experience with eCTD publishing platforms such as Lorenz docuBridge, Extedo eCTDmanager, or comparable tools
In-depth knowledge of ICH guidelines, global regulatory requirements, and industry data standards, including CDISC
Extensive experience working with Regulatory Information Management (RIM) systems and document management platforms such as Veeva Vault, SharePoint, and Documentum
Company
Clark Davis Associates
Clark Davis Associates offers staffing, recruiting and other professional services.
11-50 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase