Provide regulatory support and guidance to various cross-functional teams
Ensure all applicable regulatory requirements are considered and appropriately incorporated into activities and deliverables for clinical and commercial products and programs
Provided regulatory support in authoring and editing of regulatory documents (e.g. Meeting requests, query responses) as needed
Manage the processing of regulatory submissions with Strategy leadership and operational support; ensures submissions are prepared in compliance with regulatory requirements and guidance documents
Proactively identify regulatory risks and provide recommendations for risk-benefit assessments risk mitigations
Monitor the external regulatory climate to inform internal customers of potential impact on long-term objectives
Manage assembly and creation of documentation supporting investigational and new drug application/biologic license application for the US FDA throughout the product’s lifecycle

Requirements

Accredited Bachelor’s Degree
8+ years R&D experience within a pharmaceutical and/or biotech industry
5+ years’ experience in Regulatory Affairs
Demonstrated proficiency in following scientific arguments
Direct experience in US drug development and regulatory submissions supporting investigational and marketing application submissions and lifecycle maintenance activities
Experience successfully supporting health authority submissions, clinical trials and critical projects while maintaining agreed timelines
Previous experience with IND filings or maintenance required
Attention to detail and strong organizational skills with the ability to meet multiple deadlines and multitask within assigned projects
Excellent oral and written communication skills across all levels of the organization

Benefits

Flexible paid time off (PTO)
Health benefits to include Medical, Dental and Vision
Company match 401k
Eligibility for a 20% bonus target based on company and individual performance
Eligibility to participate in the company’s long-term incentive plan

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

regulatory submissionsregulatory documentsIND filingsdrug developmentregulatory affairsrisk-benefit assessmentsclinical trialsmarketing application submissionslifecycle maintenancebiologic license application

Soft Skills

attention to detailorganizational skillsmultitaskingoral communicationwritten communication

Certifications

Bachelor’s Degree