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Manager, Global Regulatory Services, PCS

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Primary Location: Mesa, Arizona, United States Full time R1327378

Job description

Regulatory Manager – Patient Centered Solutions

IQVIA provides scientific services spanning clinical trials, real world evidence, and consulting in all areas of the product lifecycle. The Patient Centered Solutions (PCS) team leads the industry in generating data to ensure that the patient voice is incorporated into the development and commercialization of medication and other drug/non-drug interventions. We focus on understanding and meeting the needs of our clients – mostly life science/pharmaceutical companies – through the application of broad consulting expertise and technical scientific knowledge to design scientifically rigorous research. This research is broad and includes qualitative (e.g. interviews, focus groups), quantitative (e.g. clinical outcome assessments (COAs)/patient-reported outcomes (PROS), preference research) and passive (e.g. digital health technology tools) approaches to understand patient, caregiver and healthcare professional experiences and expectations of disease and treatment.

To meet our client expectations and retain the excellent reputation built up over time the IQVIA PCS team is committed to recruiting, training and supporting driven individuals who have both consulting skills and life science skills that can be applied to PCS research activities. Individuals joining us are assured of a rewarding and progressive career in patient-focused research. You’ll have the opportunity to address challenging client issues, across multiple geographies with a hands-on influence in developing and delivering solutions.  We operate in a truly multi-cultural, collegial and collaborative work environment that is rich in development and growth.

Role & Responsibilities

As a Regulatory Manager within the PCS team at IQVIA, you will take on a variety of roles that focus primarily within the following core areas: client/project support, regulatory-focused business development, and regulatory consulting roles. The main focus of a manager is to deliver outstanding client service including planning and execution of PCS regulatory-focused workstreams. The manager will be relied on to proactively seek out and apply pertinent information to support strategic consulting projects as well as external engagement, development of internal processes and documents.

As a Regulatory Manager within PCS, you will work directly with clients to develop business opportunities and deliver projects ensuring that delivery results are at high levels of client satisfaction, and strategic and scientific excellence. You will join a thriving PCS business with existing client accounts with scope for expansion, and the support of a broad array of IQVIA colleagues with connections to introduce PCS to new clients.

  • Support development and delivery of insightful, value-added regulatory strategies that address complex client issues
  • Support sales efforts, including developing and responding to proposals, to win PCS work
  • Own PCS regulatory workstreams on patient experience research and COA Consulting projects
  • Provide direction, advice, and intellectual leadership to clients and delivery teams
  • Contribute to PCS solution building and thought leadership initiatives
  • Contribute to the enhanced awareness of PCS in the marketplace, e.g. through speaking engagements, client meetings, and publications
  • Participate in annual performance review team processes
  • Engage in recruitment and selection of new staff
  • Remain current on industry, clients, and competitive trends and directions in order to anticipate and identify new business challenges and issues with assigned clients

About You


Candidates interested in joining our Patient Centered Solutions team as a Regulatory Manager should have:

  • Experience with biopharmaceutical regulatory processes
  • Experience with regulatory management that included patient experience data
  • Demonstrable analytical, interpretative and problem-solving skills
  • Knowledge of regulatory guidance documents and scientific guidelines relating to clinical outcome assessments
  • Able to draft regulatory submission documentation including meeting materials and dossiers
  • Able to conceptually fit individual scientific and strategy tasks together to determine how the overall project goal will be achieved
  • Enables others to perform, sets clear direction and delegates fairly and appropriately, allowing direct reports the means to achieve their goals
  • Strong capability in managing large and/or multiple projects and juggling priorities so that deadlines are met while retaining consistently high quality outcomes
  • Experience working in sizable/ multi-disciplined teams and leading staff
  • Excellent interpersonal skills and ability to work effectively with others in and across the organization to accomplish team goals
  • Knowledge of key issues in patient experience research and current developments in the pharmaceutical and healthcare industries
  • Excellent organizational, time management, and problem solving skills

In addition to the skills and experience above a Regulatory Manager should have:

  • Bachelor’s degree or equivalent, graduate degree or MBA not required but a plus
  • 5+ years of related experience within regulatory affairs, regulatory operations and/or regulatory information management in consulting and/or the life sciences industry
  • Excellent presentation, communication and client influencing skills
  • A willingness and ability to travel
  • Right to live and work in the recruiting country

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoe

As the COVID-19 virus continues to evolve, IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding vaccination status. https://jobs.iqvia.com/covid-19-vaccine-status

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