Principal, Regulatory Science And Strategy - Real World Solutions

Iqvia; Milano; Ibrido; EUR 140.000 - 210.000; Tempo pieno

Descrizione del lavoro

IQVIA cerca un Principal nel team Regulatory Science and Strategy (RSS) per guidare l'offerta di strategie regolatorie e studi RWE, collaborando con team interni ed esterni. Sarà responsabile della relazione con i clienti, della qualità delle consegne e dello sviluppo di nuove opportunità di business.

Il ruolo richiede leadership, conoscenza approfondita di EMA/FDA e una laurea in discipline correlate, con esperienza significativa nel settore life sciences. Disponibilità a viaggiare.

Competenze

• Esperienza comprovata in scienze regolatorie o strategia di prodotto nel life sciences.
• Studi sull'ambiente regolatorio EMA/FDA e conoscenza delle normative.
• Fluenza in inglese (scritto e parlato) richiesta.

Mansioni

• Guidare vendite e delivery di progetti RSS regolatori end-to-end e coordinare team.
• Supportare team cross-funzionali nella generazione di studi RWE per contesti regolatori.
• Contribuire a intelligence normativa e monitorare ambienti esterni rilevanti.
• Gestire soddisfazione del cliente e qualità delle consegne.
• Consigliare su strategie di regolamentazione EMA e percorso regolatorio.
• Mentorare colleghi junior e contribuire a sviluppo del RSS.

Conoscenze

Regulatory expertise

Real world data

Regulated products

Client relationship mgmt

Business development

Solution selling

Communication

Team collaboration

People development

Decision making & adaptability

Formazione

Life sciences degree

Graduate degree preferred

Descrizione del lavoro

Descrizione dell’offerta di lavoro

Questa posizione è in IQVIA

Il processo di selezione sarà interamente gestito IQVIA.

Questa opportunità è disponibile in Amsterdam - Netherlands, Madrid - Spain, Milan - Italy, Vienna - Austria, Frankfurt - Germany, London - United Kingdom, Illkirch-Graffenstaden - France

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IQVIA is focused on using data and science to help healthcare clients find better solutions for their patients. Individuals joining us are assured of a rewarding career in Life Sciences Consulting, with opportunities to address diverse and challenging client problems, contribute to cross-geography engagements, interact with senior client leaders, and gain exposure to a multicultural and collaborative work environment. About our team – Regulatory Science and Strategy (RSS) The Regulatory Science and Strategy (RSS) group sits within IQVIA's Real World Solutions business and supports life sciences clients in using real world evidence (RWE) more widely and effectively for regulatory purposes. RSS sells and delivers as a unified team, partnering with clients on regulatory strategy, study design, and submission planning across drugs, biologics, and devices. Our work spans externally controlled trials, post-marketing requirements (PMRs/PMCs), post-authorization safety studies (PASS), drug utilization studies (DUS), and emerging regulatory technology. We are strategic thinkers, deep subject matter experts, and creative at our core. We are collaborative, intellectually curious, and entrepreneurial. About the role: As a Principal (Director-level) within RSS, you will own delivery leadership, drive business development, and serve as a subject matter expert across two connected areas: selling and delivering standalone regulatory strategy engagements and cross-functional RWE studies for regulatory decision-making. Your work will focus primarily on several areas: First, a Principal is expected to lead high-quality standalone regulatory strategy engagements, build trusted relationships with new and existing clients, and strengthen IQVIA's regulatory science and strategy capabilities. Second, the Principal acts as a subject matter expert on the use of RWE across the regulatory lifecycle, partnering cross-functionally with IQVIA Real World Solutions teams to shape, sell, and deliver RWE studies from pre-submission strategy through approval and post-market commitments. An in-depth understanding of EMA expectations is essential, with the ability to translate those expectations into study designs and submission strategies that clients can act on. Specifically, as a member of the RSS team, the Principal participates in regulatory strategy proposal development, advises on regulatory pathways, and supports cross-functional proposal strategy and delivery for externally controlled trials, PASS, DUS, RegTech advisory work, and broader RWE-for-regulatory engagements. In addition we expect you to make a key Team and operational contributions to RSS, including mentorship and capability building amongst your junior colleagues

• Lead sell and delivery of standalone RSS regulatory strategy engagements, owning workstreams end-to-end and supporting team members on complex programs.
• Support cross-functional IQVIA Real World Solutions teams in selling and delivering RWE generation programs for regulatory audiences, including externally controlled trials, premarket uses of RWE, PASS, and PMR/PMC fulfilment.
• Contribute to RSS regulatory intelligence activities, monitoring the external regulatory environment and surfacing emerging information relevant to IQVIA's offerings and clients.
• Act as a day-to-day owner of the regulatory science element of client engagements, with responsibility for client satisfaction and delivery quality.
• Advise on strategy and delivery plans for RSS services, with a focus on EMA RWE activities and lifecycle management, supported by working knowledge of FDA, MHRA, Health Canada, and PMDA.
• Maintain working familiarity with the activities and outputs of EMA and their impact on global harmonization of RW efforts.
• Identify follow-on work and new revenue opportunities with existing clients, and support business development efforts with new client organizations.
• Collaborate across IQVIA when client requirements span regulatory affairs, clinical development, and real world insights.
• Provide direction, advice, and intellectual leadership to delivery teams and clients.
• Contribute high-level input to client reports and presentations, and deliver findings to clients directly.
• Mentor and coach junior consultants, sharing subject matter expertise to build RSS capability.
• Participate in annual performance review processes and in recruitment of new staff.

Skills and Experience The successful candidate will have a track record of success across most of the following competencies:

• Industry and regulatory expertise: Maintains a constant focus on regulators, industry, and client trends in life sciences. Applies this knowledge to active client engagements and to business development.
• Real world data expertise: Ability to advise on the design of real world studies to meet regulatory requirements, including externally controlled trials, PASS, PMR fulfillment, etc.
• Regulated medical product experience: Ability to speak with senior client stakeholders about EMA requirements, guidance, and expectations, with working knowledge of FDA, MHRA, Health Canada, and PMDA.
• Client relationship management and delivery: Day-to-day owner of client engagements, focused on client satisfaction and outstanding deliverables, with the ability to manage multiple workstreams in parallel.
• Business development: Active contributor to proposal development and pre-sales meetings for standalone regulatory strategy opportunities and cross-functional RWE study opportunities with new and existing client organizations.
• Solution selling: Ability to identify client pain points and shape custom solutions for life sciences clients.
• Communication and executive presence: Expresses ideas clearly and concisely, and tailors messaging to the audience.
• Cooperative teamwork: Builds supportive relationships within RSS and across IQVIA, based on trust and respect.
• Management of others: Sets clear direction and develops junior team members by delegating appropriately and creating stretch opportunities.
• Coping with decision-making, customer focus, flexibility, influencing, initiative, innovation, planning and organizing, strategic vision, and technological orientation.

Qualifications and Other Requirements

• A strong academic track record in a life science-related discipline or professional equivalent. A relevant graduate degree (PharmD, PhD, MD, MPH, or MS) is preferred.
• At least 7 years of professional experience, with a meaningful portion focused on regulatory science, regulatory strategy, or product review. Prior experience at EMA or another health authority is highly valued.
• Previous experience in life sciences consulting or professional services is preferred.
• Evidence of consistent career progression.
• A track record of project leadership and people development.
• 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 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.

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