Job Description

Associate Director/Director, RA-GDP Contractor

Join to apply for the Associate Director/Director, RA-GDP Contractor role at Shionogi Inc. (U.S.)

Support the Regulatory Affairs (Executive Director) in developing and executing regulatory strategies for antiviral programs globally or within specific regions

Responsibilities

1. Assist in preparing presentations, reports, and strategic documents for leadership discussions.
2. Maintain and track project timelines, action items, and regulatory deliverables to ensure smooth execution.
3. Organize and document meeting minutes and action items to support strategic planning.
4. Contribute to the preparation and submission of regulatory documents related to antiviral programs to regulatory authorities.
5. Conduct research on regulatory trends, competitor strategies, and market intelligence to provide background insights.

Coordinate with Global Regulatory Counterparts to Align Regional Strategies and Submissions with Global Development and Regulatory Strategy Plans

Specific Tasks

1. Maintain centralized regulatory meeting minutes to track planning and progress of key submissions, including timelines, status updates, and regulatory requirements across regions.
2. Schedule and organize cross-functional and cross-regional meetings, prepare agendas, and summarize discussions.

Manage Regulatory Risks and Develop Mitigation Strategies for Antiviral Initiatives

Specific Tasks

1. Maintain a regulatory risk log, tracking risks, mitigation plans, and follow-up actions.
2. Conduct literature reviews and research on regulatory guidelines to provide preliminary insights.
3. Draft initial risk assessment summaries for leadership review and refinement.

Provide Regulatory Guidance and Support for Post-Marketing Activities Related to Marketed Anti-Infectives

Specific Tasks

1. Assist in preparing draft regulatory documents under senior regulatory staff guidance.
2. Track post-marketing requirements and submission deadlines to ensure compliance.
3. Review documents for formatting, consistency, and completeness before submission.
4. Organize historical regulatory data for reference and audits.

Prepare Regulatory Updates, Progress Reports, and Strategic Recommendations for Senior Leadership

Specific Tasks

1. Gather regulatory intelligence and compile data for leadership reports.
2. Assist in drafting initial versions of regulatory updates for review.
3. Create visual summaries, presentations, and dashboards to convey regulatory insights.
4. Maintain a library of past regulatory updates for consistency.

Establish Deliverables & Performance Expectations

• Complete projects such as preparation of Type C/B/D meetings for antivirals in clinical development.
• Contribute to finalizing regulatory strategy plans and implementation for antivirals, including IND applications and NDAs.
• Ensure compliance with FDA, EMEA, PMDA guidances.
• Performance will be monitored via regular reviews by the Executive Director, including review of meeting minutes, timelines, and submission quality.

Minimum Qualifications

• Bachelor's degree in life sciences, pharmacy, bioscience; advanced degree preferred.
• 7+ years of experience in regulatory affairs within pharma or biotech, preferably with antivirals.
• Ability to work effectively in cross-functional teams.
• Strong knowledge of FDA, ICH guidelines, and regional regulatory requirements.
• Excellent communication and interpersonal skills.

Travel Requirements

• Up to approximately 10% domestic and/or international travel.

Work Policy

• Must live within commuting distance to Florham Park, NJ. Office presence required at least 50% of the time per month.

Disclaimer

This job description may change or be supplemented at any time without notice.

EEO Statement

Shionogi Inc. is an equal opportunity employer supporting diversity, including individuals with disabilities and veterans. All qualified applicants will be considered without discrimination based on protected characteristics.

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