Manager, Regulatory Affairs
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Job Location:
Monthly Salary:
Posted on:
7 hours ago
Vacancies:
1 Vacancy
Job Summary
About IQVIA
IQVIA is a global leader in healthcare intelligence committed to defining and delivering the future of healthcare. Our brand stands for innovation integrity and impactconnecting data technology and expertise to improve outcomes for patients and partners worldwide. We foster a culture of collaboration diversity and continuous learning empowering our teams to make a difference every day.
The Role
As a Regulatory Publishing & Submission Team Lead you will manage a high-performing team supporting clinical trial and marketing authorization activities for both internal and external clients. Youll ensure consistent regulatory support drive operational excellence and champion IQVIAs commitment to quality and compliance.
Experience Required: 1215 years in regulatory publishing or submissions
Languages: Professional proficiency in French and English - required; intermediate Japanese and basic Spanish - nice to have.
Key Responsibilities:
- Lead mentor and develop regulatory publishing staff in line with IQVIAs values and policies
- Oversee creation assembly and publishing of global paper and electronic submissions (NDAs INDs Annual Reports etc.)
- Ensure compliance with regulatory processes and readiness for audits
- Collaborate with cross-functional teams to ensure documents meet regulatory and company standards
- Engage directly with clients providing strategic consultancy and delivering business development presentations
- Contribute to tool development training and continuous improvement initiatives
- Maintain expertise in publishing systems (RIM Smart Insight eCTDXpress Extedo Lorenz Veeva Vault EMA Gateway CESP MHRA Portal)
What Were Looking For
- Proven leadership in regulatory publishing/submissions (1215 years)
- Strong technical knowledge of publishing systems and software
- Life Science background (MSc MPharma)
- Excellent communication and project management skills
- Ability to work independently and as part of a global team
- Commitment to IQVIAs values of innovation collaboration and customer focus
Why IQVIA
- Be part of a purpose-driven organization shaping the future of healthcare
- Work in a diverse inclusive and supportive environment
- Access to cutting-edge technology and professional development opportunities
- Competitive compensation and benefits
Ready to make an impact
Apply now and help us deliver smarter healthcare solutions worldwide.
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
