Sr. Regulatory Program Manager - 173598

Zachary Piper SolutionsAnywhereAdded 2d ago

Regulatory Affairs Associate

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Job description

Piper Companies is currently looking for an experienced Sr. Regulatory Program Manager to work remotely (East Coast Preferred) for a leading pharmaceutical company. The Sr. Regulatory Engagement Manager will play a significant role in leading company adherence to eCDT 4.0 regulatory requirements. Responsibilities for the Sr. Regulatory Program Manager include:Lead a top 30 pharmaceutical organization in compliance efforts with eCDT 4.0 regulatory changesUtilize consulting skillset such as Program management, Process modeling, process optimization, change management and vendor management to oversee full project life cycleAct as subject matter expert on regulatory operations, eCTD 4.0 regulations, including transition to eCTD 4.0, IDMP awareness, submission planning/tracking, and forecastingLead project communication with local project team, internal stakeholders, international UK based company representatives and vendorsQualifications for the Sr. Regulatory Engagement Program include:A minimum of 8+ years within pharmaceutical manufacturing regulatory affairs3+ years of project management leading regulatory initiatives within pharmaceutical development and manufacturingHands-on experience implementing eCDT 4.0 regulatory changesHands on experience with Veeva systemsB.S. in regulatory affairs or related field requiredCompensation for the Sr. Regulatory Program Manager include:Compensation range is $90.00/hr - $100.00/hr dependent upon experienceComprehensive benefits packageKeywordsSr. Regulatory Program Manager, Regulatory Affairs, Project Management, Program Management, eCDT 4.0, Regulatory Compliance, Pharmaceutical Research, Pharmaceutical Manufacturing, Science, comprehensive benefits package, Health, Vision, Dental.

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