21 час назад
Regulatory Project Manager (Pharmaceutical Regulatory Affairs)
97 200 - 270 700$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Regulatory Project Manager (Pharmaceutical Regulatory Affairs): Supporting global pharmaceutical development programs by translating regulatory strategy into integrated plans and managing milestones, timelines, dependencies, risks, and regulatory deliverables with an accent on global submissions and registration activities. Focus on facilitating regulatory subteam governance, coordinating cross-functional stakeholders, and driving accountability across US, EU, Canada, Australia, and UK programs.
Location: Durham, North Carolina, United States of America
Annual base pay: $97,200–$270,700, with potential additional incentives, bonuses, and benefits.
Company
IQVIA provides clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries.
What you will do
- Support one or more global development programs across early- and late-stage development.
- Translate regulatory strategy into integrated, executable plans.
- Manage milestones, timelines, dependencies, risks, and regulatory deliverables.
- Coordinate alignment and accountability across global regulatory teams and cross-functional stakeholders.
- Plan and facilitate Global Regulatory Subteam meetings, track decisions and actions, and ensure follow-through.
Requirements
- Significant pharmaceutical or biotechnology experience with substantial regulatory affairs and/or regulatory program management experience.
- Experience supporting regulatory strategy and execution across development stages, including major submissions and global registration activities.
- Strong project and program management skills, including complex timelines, interdependencies, risks, and cross-functional deliverables.
- Experience working in a matrixed global organization with senior regulatory and cross-functional stakeholders.
- Strong communication, facilitation, organizational, and influencing skills.
- Experience supporting programs involving the US, EU, Canada, Australia, and UK.
Nice to have
- Exposure to APAC and LATAM markets.
- Familiarity with Smartsheet, Microsoft Office and PowerPoint-based timeline visualization tools, or Veeva RIM.
- Experience with post-marketing regulatory activities.
Culture & Benefits
- Work within a global regulatory science organization.
- Collaborate with international regulatory and cross-functional teams.
- Potential incentive plans, bonuses, and additional compensation depending on the position.
- Health, welfare, and other benefits may be provided.
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