Job Overview
Individual contributor with advanced knowledge acquired from at least 8 years of relevant industry experience. Working independently with limited supervision, the individual will provide strategic regulatory expertise and leadership for clinical trial applications and lifecycle management activities, with a strong focus on EU Clinical Trials Regulation (CTR) submissions and Clinical Trials Information System (CTIS) management.
Essential Functions
Act as Regulatory Global Team Leader for regulatory projects and/or serve as Regulatory Project Manager for stand-alone projects
Lead the preparation, review, and submission of regulatory documentation, ensuring high quality and compliance with applicable regulations and guidelines
Provide strategic regulatory advice to clients, including EU submission strategy, Reporting Member State (RMS) selection, scientific advice planning, and lifecycle management activities
Lead and support EU CTR submissions, including initial CTA submissions, substantial modifications, Requests for Information (RFIs), and CTIS lifecycle activities
Manage communications and interactions with regulatory authorities, including support for and participation in agency meetings.
Build and maintain strong client relationships, acting as a trusted advisor on regulatory matters and proactively resolving issues
Manage project timelines, deliverables, budgets, and out-of-scope activities to ensure successful project execution and financial performance
Mentor and provide guidance to junior colleagues, including review of regulatory documentation and support for training and professional development
Support business development activities, including travelling to and participating in bid defense meetings and client presentations
Contribute to the development, revision, and review of regulatory and cross-functional Standard Operating Procedures (SOPs)
Support global, regional, and cross-functional regulatory initiatives and process improvement activities
Remain current with regulatory intelligence, evolving regulations, and industry best practices
Perform additional duties as assigned to support business and departmental objectives
Qualifications
Experience
Minimum of 8 years of regulatory affairs experience within the pharmaceutical, biotechnology, CRO, or related industry
Minimum of 2 to 3 years of hands-on EU CTR and CTIS experience, including preparation, review, and submission of Part I initial Clinical Trial Applications (CTAs)
Demonstrated experience managing CTIS lifecycle activities, including RFIs, substantial modifications, and ongoing trial maintenance
Experience interacting with Reporting Member States (RMS) and other European regulatory authorities
Proven experience advising clients on EU regulatory strategy, including RMS selection, submission planning, and scientific advice strategy
Advanced understanding of EU clinical trial regulations, guidance documents, and CTIS requirements
Strong understanding of regulatory documentation requirements across different therapeutic areas, development stages, and product modalities
Experience with combination product trials is advantageous
Experience in regulatory strategy development, timeline planning, budget management, and documentation gap assessments
Ability to independently manage multiple projects and priorities while meeting challenging timelines
Strong project leadership and stakeholder management skills
Excellent written and verbal communication skills, including preparation of high-quality regulatory documents and client-facing presentations
Ability to establish and maintain effective relationships with clients, colleagues, and regulatory authorities
Proficiency in Microsoft Office and relevant regulatory systems and publishing tools
Applicable certifications and licenses as required by local regulations and business needs
Willingness to support cross-functional and global initiatives as required
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 https://jobs.iqvia.com.
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
At IQVIA, we believe that diversity, inclusion, and belonging empower our mission to accelerate innovation for a healthier world. We create a culture of belonging by valuing the perspectives of all talented employees worldwide and providing them with the opportunity to power smarter healthcare for everyone, everywhere. When our talented employees bring their authentic selves and their diverse experiences to work, they enable us to accomplish extraordinary things. Multifaceted thought processes spark innovation. Multi-talented collaboration harnesses innovation to deliver superior outcomes. Likewise, as part of this culture, IQVIA is committed to ensuring effective equality between women and men, integrating it as a strategic principle in its corporate and human resources policies.
