What are the responsibilities and job description for the AD / Dir Regulatory Affairs Strategy position at Joulé?
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
Responsibilities
ESTABLISH DELIVERABLES & PERFORMANCE EXPECTATIONS
TRAVEL REQUIREMENTS
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
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