Job Title: AD - Dir Regulatory Affairs Strategy
Location: Florham Park, NJ (50% hybrid)
Type: contract
 
Overview
Support the Regulatory Affairs (Executive Director) in developing and executing regulatory strategies for antiviral programs globally or within specific regions


Requirements Bachelor's degree in a scientific discipline such as life sciences, pharmacy, bioscience; advanced degree preferred. 7+ years of experience in regulatory affairs within the pharmaceutical or biotech industry, with a focus on antiviral products preferred. Demonstrated ability to work effectively in a cross-functional team environment. Strong knowledge of regional regulatory requirements and guidelines, including FDA regulations and ICH guidelines. Excellent communication and interpersonal skills.
Responsibilities Assisting in preparing presentations, reports, and strategic documents for leadership discussions. Maintaining and tracking project timelines, action items, and regulatory deliverables to ensure smooth execution. Organizing and documenting meeting minutes and action items to support the leader’s strategic planning. Contributing to the preparation and submission of regulatory documents related to antivral programs to regulatory authorities. Conducting research on regulatory trends, competitor strategies, and market intelligence to provide background insights. Assist in Coordinating with Global Regulatory Counterparts to Align Regional Strategies and Submissions with Global Development Plans and Regulatory Strategy Plans
  ESTABLISH DELIVERABLES & PERFORMANCE EXPECTATIONS Preparation of Type C/B/D Meetings for antivirals in clinical development (as needed) Contributions to and finalization of regulatory strategy plans and implementation for antivirals in development (including 2 new IND applications and 1 NDA) Knowledge of and Compliance with FDA, EMEA, PMDA guidances Performance will be monitored via regular review by the Executive Director and feedback on the strategist's work. This will include review of meeting minutes, timelines and draft submission packages.  Performance metrics will include completion of regulatory submissions, adherence to timelines, and the quality of submissions The Executive Director, Regulatory Affairs will review and approve completed work.

TRAVEL REQUIREMENTS Percentage or frequency of travel: this position may require up to approx. 10% domestic and/or international traveling  

Benefits
System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan. 

 

Ref: #568-Clinical

System One, and its subsidiaries including Joulé, ALTA IT Services, TeamPeople, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.