Associate Director Product Management For Language Solutions - Regulatory Affairs

IQVIA Language Solutions seeks a strategic, client-facing Associate Director to serve as a Subject Matter Expert (SME) in regulatory and market access translation strategies. This role focuses on designing and deploying compliant, fit-for-purpose multilingual solutions for regulatory submissions, labelling, and market access documentation across global markets.

In addition to leading client engagements and shaping IQVIA’s offering strategy, this role is accountable for developing standard operating procedures (SOPs), work instructions, and internal / external training to ensure quality, scalability, and regulatory alignment across delivery teams.

Key Responsibilities

Client-Facing Strategic Support

• Lead high-level consultations with sponsor clients on multilingual requirements for :
• EMA / FDA-compliant labelling (QRD templates, blue box, SmPC, PIL, PL)
• Market access and HTA documentation (G-BA, NICE, AIFA, etc.)
• Participate in RFP / RFI responses, solutioning workshops, and bid defenses.
• Serve as a trusted advisor to VP-level stakeholders in Regulatory, Market Access, HEOR, and Clinical Operations.
• Design and formalize SOPs, work instructions (WI), and controlled documents to standardize regulatory and access-related translation processes across geographies and therapeutic areas.
• Lead the governance and periodic review of documentation to align with updates from EMA, FDA, Health Canada, etc.
• Ensure SOPs reflect evolving needs in structured content, digital labelling, electronic submissions, and multilingual packaging.

Training & Capability Building

Cross-Functional Leadership

Experience & Qualifications

Required :

Preferred :

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 .

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.

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