Senior Regulatory Science and Strategy Lead

Overview

Individuals joining us are assured of a rewarding and progressive career in life sciences consulting. You’ll have the opportunity to address challenging client issues, across multiple geographies with a hands-on influence in delivering solutions. We operate in a truly multi-cultural, collegial and collaborative work environment that is rich in development and growth.

Role
As a Regulatory Science and Strategy Senior Principal within IQVIA’s EMEA RWS business, you will take on a variety of roles that focus primarily within the following core areas:

client/project leadership,

maintaining and further developing expertise on the regulatory landscape (focusing on real world evidence and the European Medicines Agency in particular),

business development,

firm/operational leadership roles

The role has two areas of focus.

Firstly, a senior principal is expected to deliver outstanding client service, while building trusted relationships with new and existing clients while enhancing our global network of regulatory science and strategy capabilities to support life science clients to use Real World Evidence more widely and effectively for regulatory purposes.

Secondly, the role encompasses acting as a subject matter expert and thought leader for Regulatory Affairs in Europe (western and eastern). It covers regulatory affairs for all phases from drug development: pre-clin, clinical, submission/approval/launch, and post-launch development and commercialization activities.

An in-depth knowledge of the entire drug development process from EMEA health authority requirements perspective e.g., European Medicine Agency (EMA) and local national competent authority is essential to success. This subject matter expert role interacts with those experienced in regulatory affairs, clinical development and real-world insights for post authorization studies. As a member of the MEP team, they participate in the development of proposal strategy and regulatory pathway including for PASS.

The role interacts with regulatory and drug development leaders around IQVIA relative to customers who require regulatory expertise. The role also interacts with Marketing and Sales/BD across IQVIA as they generate customer requests.

Finally, this role is part of the senior/strategic face of IQVIA to customers for IQVIA EMEA regulatory affairs services connected to Post Authorisation Safety Studies(PASS), Drug Utilisation Studies and external comparators studies . Since the European pharma market is one of the largest in the world, this requires considerable breadth of knowledge and experience.

Responsibilities

Support IQVIA Real World Solutions teams to sell and deliver customer programs of Real World Evidence generation for regulatory audiences (notably Post Authorisation Safety Studies, Drug Utilisation Studies and External Comparator Studies)

Lead European regulatory intelligence activities. Ensure a robust process to monitor the external regulatory environment and to identify and communicate new or emerging information that is relevant to IQVIA innovative offerings and to our clients’ needs.

Remain current on emerging regulatory frameworks, pivotal regulatory decisions, and industry trends in order to anticipate and identify new business challenges and issues with assigned clients.

Shape and influence regulatory strategy to benefit company, based on emerging regulatory frameworks, scientific innovation, and IQVIA’s Real World Solutions portfolio

Create and elevate new business opportunities through the identification of value-added follow-on work and identify new revenue opportunities with existing and new client organizations.

Act as principal owner of regulatory science element of client engagements; ultimate responsibility for client satisfaction and delivering high levels of quality/added value: Specifically:

Advisor on the strategy to deliver EMEA regulatory services to customers concerning PASS, DUS and external comparators. The role requires deep understanding of customer needs and develops appropriate strategy and delivery plans for services. Key services include regulatory consulting and fulfilling EMEA requirements for life cycle management especially regarding Post authorisation Safety Studies.

Deep knowledge of the activities, outputs and ongoing workstreams of the PRAC, CHMp, EMA and EnCEPP are essential

Capability to work collaboratively across IQVIA when customer requirements involve regulatory affairs services

Customer experience developing, delivering, and selling regulatory services to biotech, small-, mid-, and large Pharma.

Provide follow-up with clients after project deliverables have been completed to ensure client satisfaction.

Allocate direction, advice, and intellectual leadership to clients and delivery teams.

Provide high level input and ensure development of client reports and presentations.

Ability to deliver all or significant portions of findings to clients.

Lead IQVIA regulatory thought leadership in concert with IQVIA’s our global network of regulatory science and strategy experts

Provide leadership, strategic direction and insight to the Regulatory Science and Strategy organization.

Participate in annual performance review team processes.

Engage in recruitment and selection of new staff.

Mentor, coach, and share subject matter expertise with others to help develop individuals and capabilities delivering world-class solutions for clients.

Skills & Experience

The successful candidate will have a track record of success across the majority of the following competencies:

Industry & regulatory expertise - Maintains a constant focus on regulators, industry, and client trends in the life sciences industry. Applies this knowledge to both active client engagements and business/client development activities.

Regulated Medical Product Experience - Ability to speak in detail with senior client stakeholders about EMA, MHRA and other regulatory bodies requirements, guidelines, and expectations, in a meaningful manner with depth of content knowledge, including emerging trends that will shape studies and broader business planning activities especially around PASS , DUS and external comparators.

Client Relationship Management and Delivery - Principal owner of client engagements to the brand and commercial functions within leading Life Sciences organizations, focused on client satisfaction and outstanding client deliverables. Proven capability to identify new revenue opportunities with existing clients & manage several opportunities in parallel

Business Development - Proven success selling complex strategy and operations engagements to the top Pharma/Life Sciences companies. Actively participate in proposal development and ongoing pre-sales meetings with potential new client organizations.

Senior Level Solution Selling - Proven ability to build relationships, identify client pain points, and develop custom solutions with senior level life science clients

Communications/Executive Presence - Expresses ideas in a clear and concise manner; tailors message to target audience with the gravitas to build relationships to sell services and recruit practitioners.

Cooperative Teamwork - Builds supportive relationships within a team, based on trust and respect. Requires listening to others, adapts to other people's different work styles and focuses on shared goals. Willing to challenge others and accepts challenges as a way of getting the best results for the team.

Coping with Pressure - A positive attitude in stressful situations or following failures. Ability to manage one’s own emotions, willing to take on challenging tasks, and energy to remain focused on those tasks when presented with obstacles.

Decision-Making - Makes clear, appropriate decisions. Performs with incomplete or ambiguous information, and while under time pressure. Resilience in making unpopular decisions when necessary and taking responsibility for outcomes and impacts of those decisions.

Customer Focus - Develops strong, lasting relationships with clients. Possesses desire to understand and satisfy customers’ needs and exceed expectations whenever possible. Concern with clients inside or outside the organization; internal customers may be other departments or individuals from the same organization.

Flexibility - Responds well to change. Positive attitude toward change and a readiness to adapt when presented with new information, new situations or shifting priorities.

Influencing - Balances the need to shape outcomes in short term while maintaining successful long-term relationships. Knows how to motivate and inspire to achieve a common goal, and demonstrates key strategic negotiation tactics. Uses personal and professional contacts to influence people across teams or organizations.

Initiative - Constantly looks for things to do. Self-confident and proactive; generates activity for themselves rather than waiting for instruction. Prepared to take risks if potential benefit in results.

Innovation - Turns creative ideas into original solutions. Produces new or different approaches in current situations and enables creativity in others. Involved in generating ideas and seeing them through to implementation.

Management of Others - Enables others to perform. Sets a clear direction and delegates fairly and appropriately allowing direct reports the means to achieve their goals. Looks for opportunities to develop individuals by encouraging them to take on greater responsibility and make decisions for themselves.

Planning and organizing - Establishes and prioritizes tasks and objectives in order to manage time and resources appropriately. Sets deadlines based on the time required, and on how each part of the plan affects others. Prepares backup plans in case the sit

Strategic Vision - Creates a clear view of the future of the business. Considers the long-term goals of the organization and defines the strategy to achieve this. Takes into account the current environment in which the business operates and anticipates future changes or challenges for the organization.

Technological Orientation - Shows comfort and aptitude using technology in order to reach goals more efficiently, and to a higher standard of quality. Welcomes advancements in technology and is willing to understand and implement them. Uses technology appropriately, and helps others to appreciate and understand the benefits of using technology.

International Experience - Has experience working across Europe and other geographies

Qualifications & Other Requirements

In addition to the skills and experience above, candidates interested in joining IQVIA in this role should have:

A strong academic track record including a life science-related discipline or professional equivalent, relevant graduate degree preferred (further personal/industry qualifications are valued)

At least 10 years professional experience in working at European Regulatory bodies e.g., EMA

Previous experience in life science consulting / professional services is preferred

Evidence of consistent career progression

Minimum of 6 years of experience focused on regulatory science, regulatory strategy, or product review

A strong track record of management, leadership and people development

A willingness and ability to travel to client locations

Fluency in English (spoken and written)

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