AD / Dir Regulatory Affairs Strategy
7 days ago
Job Title: AD or Director, Regulatory Affairs Strategy
Location: Florham Park, NJ (10 days onsite per month)
Type: 12-month contract
Must haves:
- Must be local for hybrid schedule - fully remote is NOT an option.
- Must have Module 5 expertise.
- Must have regulatory strategy experience in IND/NDA development, not just life cycle management.
- Must have regulatory strategy experience in IND/NDA development, not just life cycle management.
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.
- 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 antiviral 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
- 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.
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.
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