Director of Regulatory Affairs

Job Description

This is a 6-month contract with potential to extend.

The role will be hybrid, with 2 days per week on-site in Florham, NJ.

You will support the Global Therapeutic Area Lead (GTAL) and Regulatory Affairs (Senior Director) in developing and executing regulatory strategies for antimicrobial/antifungal programs globally or within specific regions.

Key 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.
• Contribute to the preparation and submission of regulatory documents related to antimicrobial/antifungal programs to regulatory authorities.
• Conducting research on regulatory trends, competitor strategies, and market intelligence to provide background insights.

Additional Responsibilities:

• Assisting in coordinating with Global Regulatory Counterparts to align regional strategies and submissions with global development plans and regulatory strategy plans.
• Maintaining centralized regulatory meeting minutes to track planning and progress of key submissions, including timelines, status updates, and regulatory requirements across regions.
• Scheduling and organizing cross-functional and cross-regional meetings, preparing agendas, and summarizing discussions.
• Assisting in managing regulatory risks and developing mitigation strategies for anti-infective initiatives.
• Maintaining a regulatory risk log, tracking identified risks, mitigation plans, and follow-up actions.
• Conducting literature reviews and research on regulatory guidelines to provide preliminary insights.
• Drafting initial risk assessment summaries for leadership to review and refine.

Post-Marketing Activities:

• Providing regulatory guidance and support for post-marketing activities related to marketed anti-infectives.
• Assisting in preparing draft regulatory documents under the guidance of senior regulatory staff.
• Tracking post-marketing requirements and submission deadlines to ensure compliance.
• Conducting basic document reviews for formatting, consistency, and completeness before submission.
• Compiling and organizing historical regulatory data for reference and audits.

Regulatory Updates and Reporting:

• Assisting in preparing regulatory updates, progress reports, and strategic recommendations for senior leadership.
• Gathering regulatory intelligence and compiling data for leadership reports.
• Assisting in drafting initial versions of regulatory updates, subject to review and refinement.
• Creating visual summaries, presentations, and dashboards to convey regulatory insights effectively.
• Maintaining a library of past regulatory updates for reference and consistency.

Deliverables and Performance Expectations:

• Establishing deliverables and performance expectations.
• Preparing Type C/B/D Meetings for antimicrobials in clinical development (as needed).
• Contributions to/finalization of regulatory strategy plans for antimicrobials in development.
• Preparation of sNDA for marketed antimicrobial.
• Knowledge of and compliance with FDA, EMEA, PMDA guidances.
• Performance will be monitored via regular review by the GTAL and feedback on the strategist's work.
• Minimum qualifications include a Bachelor's degree in a scientific discipline such as life sciences, pharmacy, bioscience; advanced degree preferred.
• 10 years of experience in regulatory affairs within the pharmaceutical or biotech industry.
• 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.