Regulatory Affairs Manager
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Job Location:
Monthly Salary:
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
At IQVIA Biotech we partner with small to mid-sized biotech companies to bring life-changing therapies to patients faster. Our teams are agile mission-driven and deeply embedded in the science. If youre passionate about regulatory strategy and want to make a real impact this is your moment.
About the Role
Were looking for an experienced Regulatory Affairs professional to lead complex global projects and contribute to the development of breakthrough therapies. This is a high-impact individual contributor role with autonomy and visibility across cross-functional teams.
Key Responsibilities:
- Serve as Regulatory Team Lead or Project Manager on global submissions guiding strategy and execution
- Draft and review high-quality regulatory and technical documentation with minimal oversight
- Engage directly with clients to resolve regulatory challenges and share insightsoften representing the team independently
- Manage project budgets monitor scope and ensure accurate revenue recognition
- Provide informal mentorship and feedback to junior team members supporting quality and consistency
Requirements:
- Several years of hands-on experience in Regulatory Affairs within biotech pharma or CRO settings
- Strong understanding of global regulatory requirements and submission pathways
- Excellent technical writing and communication skills
- Financial acumen and experience managing project budgets
- A collaborative mindset and passion for innovation in biotech
Why IQVIA Biotech
- Work with cutting-edge biotech clients on first-in-class therapies
- Flat structure and fast decision-makingyour voice matters
- Flexible working arrangements and a culture of inclusion
- Competitive compensation bonus schemes and clear career growth pathways
- Be part of a team thats redefining whats possible in clinical development
IQVIA is a leading global provider of clinical research services commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at
Required Experience:
Manager
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
About Company
IQVIA is the Human Data Science Company™. We are inspired by the industry we serve and provide solutions that enable life sciences companies to innovate with confidence, maximize opportunities and ultimately drive human health outcomes forward. Our approach is Human Data Science – a d ... View more
