11 дней назад
RIO Execution Hub (EH) Manager, Sr. Manager (Regulatory Affairs)
Вакансия из Hirify Global, списка международных tech-компанийДля мэтча и отклика нужен Plus
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
RIO Execution Hub (EH) Manager, Sr. Manager (Regulatory Affairs): Coordinating regulatory submissions, dossier components, lifecycle updates, and operational support for assigned countries, clusters, and regions with an accent on submission logistics, compliance, and cross-functional delivery. Focus on managing complex submission timelines, resolving regulatory operations risks, improving dossier execution workflows, and applying digital tools and AI to increase operational efficiency.
Location: Makati City, Philippines
Company
operates in the pharmaceutical and life sciences sector, supporting regulatory activities that enable compliant product submissions and patient access.
What you will do
- Lead and coordinate moderate to complex regulatory submissions, including growth submissions and complex lifecycle activities.
- Plan submission timelines, work plans, deliverables, risk assessments, and mitigation strategies.
- Author, review, maintain, compile, and coordinate Module 1 dossier components and other submission-ready documents.
- Coordinate translations, document receipt, local ancillary legalization, dossier quality review, and submission readiness.
- Manage simple Health Authority query responses and coordinate subject matter experts on more complex responses.
- Drive continuous improvement, digital enablement, resource planning, and cross-functional regulatory operations projects.
Requirements
- Bachelor’s degree or equivalent in Pharmacy, Life Sciences, Business, or Information Technology.
- Minimum of 5+ years of relevant experience for Manager roles and 7+ years for Senior Manager roles.
- Master’s-level education in a scientific, technical, or information management discipline is desirable.
- Fluent English is required. Multilingual skills are desirable.
- Experience in regulatory operations, regulatory submissions, quality, compliance, or the pharmaceutical sector is preferred.
- Strong project management, regulatory systems, document management, Microsoft Office, communication, decision-making, and problem-solving skills are required.
Nice to have
- Familiarity with pharmaceutical organizational structures, systems, and culture.
- Understanding of country and cluster regulatory requirements and trends.
- Portuguese or other multilingual capability.
Culture & Benefits
- Cross-functional collaboration with global, regional, cluster, and local stakeholders.
- Opportunities to contribute to transformation, automation, and operational excellence initiatives.
- Work involving diverse cultures, functions, and geographic regions.
- Commitment to quality, compliance, continuous learning, digital fluency, and innovation.
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