Shionogi Inc. (U.S.)
Associate Director/Director, Regulatory Affairs -GDP Contractor
Shionogi Inc. (U.S.), Florham Park, New Jersey, us, 07932
Associate Director/Director, RA-GDP Contractor Join to apply for the
Associate Director/Director, RA-GDP Contractor
role at
Shionogi Inc. (U.S.)
A variety of soft skills and experience may be required for the following role Please ensure you check the overview below carefully. Support the Regulatory Affairs (Executive Director) in developing and executing regulatory strategies for antiviral programs globally or within specific regionsResponsibilities
Assist in preparing presentations, reports, and strategic documents for leadership discussions. Maintain and track project timelines, action items, and regulatory deliverables to ensure smooth execution. Organize and document meeting minutes and action items to support strategic planning. Contribute to the preparation and submission of regulatory documents related to antiviral programs to regulatory authorities. 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 PlansSpecific Tasks
Maintain centralized regulatory meeting minutes to track planning and progress of key submissions, including timelines, status updates, and regulatory requirements across regions. Schedule and organize cross-functional and cross-regional meetings, prepare agendas, and summarize discussions. Manage Regulatory Risks and Develop Mitigation Strategies for Antiviral InitiativesSpecific Tasks
Maintain a regulatory risk log, tracking risks, mitigation plans, and follow-up actions. Conduct literature reviews and research on regulatory guidelines to provide preliminary insights. Draft initial risk assessment summaries for leadership review and refinement. Provide Regulatory Guidance and Support for Post-Marketing Activities Related to Marketed Anti-InfectivesSpecific Tasks
Assist in preparing draft regulatory documents under senior regulatory staff guidance. Track post-marketing requirements and submission deadlines to ensure compliance. Review documents for formatting, consistency, and completeness before submission. Organize historical regulatory data for reference and audits. Prepare Regulatory Updates, Progress Reports, and Strategic Recommendations for Senior LeadershipSpecific Tasks
Gather regulatory intelligence and compile data for leadership reports. Assist in drafting initial versions of regulatory updates for review. Create visual summaries, presentations, and dashboards to convey regulatory insights. 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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Associate Director/Director, RA-GDP Contractor
role at
Shionogi Inc. (U.S.)
A variety of soft skills and experience may be required for the following role Please ensure you check the overview below carefully. Support the Regulatory Affairs (Executive Director) in developing and executing regulatory strategies for antiviral programs globally or within specific regionsResponsibilities
Assist in preparing presentations, reports, and strategic documents for leadership discussions. Maintain and track project timelines, action items, and regulatory deliverables to ensure smooth execution. Organize and document meeting minutes and action items to support strategic planning. Contribute to the preparation and submission of regulatory documents related to antiviral programs to regulatory authorities. 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 PlansSpecific Tasks
Maintain centralized regulatory meeting minutes to track planning and progress of key submissions, including timelines, status updates, and regulatory requirements across regions. Schedule and organize cross-functional and cross-regional meetings, prepare agendas, and summarize discussions. Manage Regulatory Risks and Develop Mitigation Strategies for Antiviral InitiativesSpecific Tasks
Maintain a regulatory risk log, tracking risks, mitigation plans, and follow-up actions. Conduct literature reviews and research on regulatory guidelines to provide preliminary insights. Draft initial risk assessment summaries for leadership review and refinement. Provide Regulatory Guidance and Support for Post-Marketing Activities Related to Marketed Anti-InfectivesSpecific Tasks
Assist in preparing draft regulatory documents under senior regulatory staff guidance. Track post-marketing requirements and submission deadlines to ensure compliance. Review documents for formatting, consistency, and completeness before submission. Organize historical regulatory data for reference and audits. Prepare Regulatory Updates, Progress Reports, and Strategic Recommendations for Senior LeadershipSpecific Tasks
Gather regulatory intelligence and compile data for leadership reports. Assist in drafting initial versions of regulatory updates for review. Create visual summaries, presentations, and dashboards to convey regulatory insights. 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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