Regulatory Strategist at Veristat | Torre
Regulatory Strategist
trending_up Invest in Torre
Veristat

Regulatory Strategist

Veristat
Posted by
Manuela Vargas Jaramillo
Full-time

Legal agreement: Employment

Compensation USD11/hour
Non-negotiable
location_on
Hybrid (United States)
Posted about 6 years ago

Responsibilities

• Provide consulting services in regulatory program strategy, overall drug development plans, strategic regulatory communications, and FDA representation. • Oversee the Regulatory Affairs aspects of client projects and project teams through the coordination of internal staff and third-party vendors. • Write, review, and provide strategic regulatory guidance on alternative pathways, such as fast track, breakthrough (and other expedited programs), orphan, and 505(b)(2), and corresponding pathways in Europe (in collaboration with EU strategist/consultant). • Assist in business development efforts by contributing to project proposals. • Prepare clients for FDA meetings, and as contracted, serve as authorized regulatory representative. • Provide strategic and regulatory compliance reviews of documents for marketed products, including marketing materials, Field Alert Reports, Individual Case Safety Reports, and Periodic Safety Updates. • Author, direct and provide strategic guidance to regulatory submissions worldwide (IND, NDA, BLA, MAA, PMA, CTA; both original applications and amendments) with support from management as needed. • Provide peer review for investigator brochures, clinical study reports, clinical protocols, and other documents as required, and contribute to the creation of strategic Clinical Development Plans (CDPs) with support from management as needed. • Prepare and present at internal and client meetings as needed to provide regulatory guidance. • Provide a high standard of customer service and ensure a complete understanding of Veristat’s offerings and responsibilities.
This job post is closed.