Regulatory Affairs Manager

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

• Bachelors Degree in Life Sciences or a related discipline required

• Masters Degree in Life Sciences or a related discipline preferred

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 .

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.