Manager, Regulatory Lead (Remote)

Alfasigma•Morristown, MN

11d•$130,000 - $165,000•Remote

About The Position

This position represents one or more Regions / Countries on the Regulatory Sub team and supports the creation/maintenance of Regional Regulatory Strategy as part of the Global Regulatory Strategy for no more than one low complexity program/single asset. The manager works under supervision and provides regulatory support to Clinical Operations and Clinical Development for various activities relating to clinical study start-up and execution, including document review, IND/CTA approval, etc.

Requirements

Bachelor’s degree (minimum 5 years relevant experience) or advanced scientific degree (MS, PhD, Pharm D; minimum 3 years relevant experience) in regulatory affairs or pharmaceutical industry and/or clinical research
Experience supporting and/or leading IND/CTA submissions
Understanding of the cross functional drug development processes (Clinical Operations, Data Management, Biostats, and Regulatory)
Strong verbal and written communications skills
Excellent project and/or program management skills
Detail-oriented and ability to achieve results across functions and levels
Ability to work effectively across a highly complex, fast paced, matrix organization
Proficiency in MS Office Suite
Learning agility and 'scalability' to take on increasing responsibility as Intercept grows
Consistent demonstration and embodiment of company core values: Collaboration, Excellence, Innovation, Integrity, Passion, Patient/Stakeholder Centricity

Responsibilities

Contribute to development and local/regional implementation of regulatory strategies for a low complexity program/single asset
Support planning, coordination, and preparation for meetings, including teleconferences with locoregional regulatory agencies
Contribute to regulatory review of study documents such as protocols, protocol amendments, ICFs, CSRs, IMPDs, IBs, and annual reports to ensure content and format meet all regulatory requirements
Contribute to development of regulatory submission plans
Assist with coordination and submission of locoregional IND/CTA submissions and maintenance activities
Support product development and lifecycle management activities
Support assessment of regulatory pathways for submissions to the FDA and other regulatory agencies
Manage multiple tasks in a fast-paced environment while keeping on task and to the company's quality standards
Drive the spirit of "ONE Team" across all functions by supporting a team approach to focus on our patients and customers as our top priorities