Associate Director/Director, Regulatory Affairs -GDP Contractor

About the position 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 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. • 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. • 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. • 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. • 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. 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. Benefits • Hourly rate position is $97 - $163. • Individual pay is determined by several factors, including job-related skills, experience, and relevant education or training. Apply tot his job