Raj Kumar Email & Phone Number

I am a passionate Regulatory Affairs professional with 14+ years of experience in regulatory publishing, submissions management, and project leadership. I specialize in managing and publishing global regulatory submissions, including INDs, BLAs, NDAs, MAAs, NDSs, and 510(k) submissions for the US, EU, and Health Canada.Throughout my career, I’ve consistently achieved corporate filing goals, led the implementation of Veeva RIM, and built in-house publishing capabilities, reducing reliance on external vendors. My expertise spans eCTD publishing, SPL submissions, and managing the full lifecycle of submission documents, ensuring regulatory compliance across all markets.Key strengths include:Submissions Management: Proficient in managing original applications, supplements, amendments, and annual reports.Leadership & Team Development: Proven track record in managing and mentoring high-performing teams while collaborating across departments such as clinical, nonclinical, regulatory, and quality.Vendor Management: Adept at managing vendor relationships, ensuring SLAs are met, and overseeing budgeting and forecasting for regulatory operations.Project Leadership: Led complex submissions and spearheaded successful implementations of regulatory tools, including Veeva RIM, to streamline processes.Cross-Functional Collaboration: Strong advocate for cross-departmental training and cooperation to enhance submission readiness and quality.

Listed skills include U.S. Food And Drug Administration, Ectd, Ich Guidelines, Regulatory Guidelines, and 15 others.