Manager - Pharma - Lifesciences Regulatory Compliance - TD
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Job Location:
Monthly Salary:
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
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IT Project Manager Regulatory Compliance (Pharma & Life Sciences)
Role Overview:
We are seeking a detail-oriented and experienced IT Project Manager to lead projects in the Regulatory Compliance space within the Pharmaceutical and Life Sciences sector. This role will oversee IT initiatives that support regulatory submissions and compliance processes including eCTD CMC labeling RIMS and submission lifecycle management. The ideal candidate will bring expertise in GxP 21 CFR Part 11 compliance and hands-on experience with platforms like Veeva Vault and other RIMS solutions.
Key Responsibilities:
- Manage end-to-end IT projects focused on regulatory compliance and submission systems.
- Lead the implementation and optimization of regulatory platforms including Veeva Vault RIM RIMS systems and other document and submission lifecycle tools.
- Partner with Regulatory Affairs Quality and IT teams to align technology solutions with evolving compliance needs.
- Oversee data integrity system validation and audit readiness in compliance with GxP and 21 CFR Part 11.
- Drive improvements in document management workflows for eCTD CMC and labeling submissions.
- Develop and manage project timelines budgets risks and deliverables using standard methodologies (Agile Waterfall or hybrid).
- Ensure effective change management training and communication across stakeholder groups.
- Collaborate with vendors and technology partners to deliver scalable and compliant solutions.
Qualifications:
- Bachelors or Masters degree in Computer Science Life Sciences Regulatory Affairs or a related field.
- 1015 years of IT project management experience within pharmaceutical regulatory operations.
- Strong knowledge of regulatory submission processes including eCTD CMC documentation and labeling.
- Experience managing RIMS platforms and tools such as Veeva Vault RIM.
- Solid understanding of GxP 21 CFR Part 11 and validation requirements in a regulated environment.
- PMP PRINCE2 or other relevant project management certification preferred.
- Excellent stakeholder engagement and communication skills.
Preferred Skills:
- Experience with data migration system validation or integration projects in a regulatory context.
- Familiarity with global regulatory requirements (FDA EMA etc.).
- Knowledge of digital submission standards and structured content authoring tools.
EY Building a better working world
EY is building a better working world by creating new value for clients people society and the planet while building trust in capital markets.
Enabled by data AI and advanced technology EY teams help clients shape the future with confidence and develop answers for the most pressing issues of today and tomorrow.
EY teams work across a full spectrum of services in assurance consulting tax strategy and transactions. Fueled by sector insights a globally connected multi-disciplinary network and diverse ecosystem partners EY teams can provide services in more than 150 countries and territories.
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
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