Regulatory Project Manager

IQVIA LLC; Durham (NC); On-site; USD 97,000 - 271,000; Full time

Job summary

IQVIA LLC is seeking a Regulatory Science professional to support global development programs within our Global Regulatory Science organization. The role involves translating regulatory strategy into executable plans, coordinating milestones across US, EU, Canada, Australia, and UK, and driving alignment with senior stakeholders.

The ideal candidate has substantial pharmaceutical or biotechnology experience in regulatory affairs and program management, strong communication and matrix-management

Qualifications

• Significant pharmaceutical or biotech experience in regulatory affairs.
• Experience supporting regulatory strategy across development stages and major submissions.
• Strong project and program management capabilities across timelines and deliverables.
• Ability to work effectively in a matrixed global organization with senior stakeholders.
• Strong communication and influencing skills, across regions and functions.

Responsibilities

• Partner with Global Regulatory Leads and cross-functional stakeholders to translate regulatory strategy into integrated, executable plans.
• Manage key milestones, timelines, dependencies, risks, and regulatory deliverables.
• Support effective Global Regulatory Subteam governance, including meeting planning and action tracking, stakeholder communication, and follow-through on regulatory activities.
• Drive alignment and accountability across global regulatory teams.
• Support regulatory development programs across US, EU, Canada, Australia, and UK; exposure to APAC and LATAM desirable.

Skills

Regulatory affairs

Regulatory program management

Cross-functional collaboration

Strategic planning

Communication

Education

Bachelor's in Life Sciences

Tools

Smartsheet

Veeva RIM

MS Office / PPT

Job description

The individual will support one or more global development programs as part of our Global Regulatory Science organization. The specific therapeutic area and program assignment will be determined based on the candidate’s experience, capabilities, and fit with the team. This individual will support across both early- and late-stage development programs.

The role will partner closely with Global Regulatory Leads and cross-functional stakeholders to translate regulatory strategy into integrated, executable plans; manage key milestones, timelines, dependencies, risks, and regulatory deliverables; and help drive alignment and accountability across global regulatory teams. The individual will also support effective Global Regulatory Subteam governance, including meeting planning and facilitation, decision and action tracking, stakeholder communication, and follow-through on key regulatory activities.

Candidates with strong experience supporting global regulatory development programs, with particular emphasis on the US, EU, Canada, Australia, and UK. Exposure to APAC and LATAM markets is desirable, although deep regional expertise in those geographies is not required.

Ideal candidates will have:

• Significant pharmaceutical or biotechnology experience, including substantial experience in regulatory affairs and/or regulatory program management.
• Experience supporting regulatory strategy and execution across development stages, including major submissions, global registration activities, and, where applicable, post-marketing activities.
• Strong project and program management capabilities, including management of complex timelines, interdependencies, risks, and cross-functional deliverables.
• Demonstrated ability to work effectively in a matrixed global organization and partner with senior regulatory and cross-functional stakeholders.
• Strong communication, facilitation, organizational, and influencing skills.
• Familiarity with regulatory systems and tools; experience with Smartsheet, Microsoft Office/PPT-based timeline visualization tools, and Veeva RIM would be beneficial.

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 proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law.

https://jobs.iqvia.com/eoe

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.

The potential base pay range for this role, when annualized, is $97,200.00 - $270,700.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide. To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere.

Thank you for your interest in growing your career with us.