At a Glance
- Tasks: Lead client consultations and develop multilingual regulatory solutions.
- Company: IQVIA is a global leader in clinical research and healthcare intelligence.
- Benefits: Enjoy a diverse culture, remote work options, and opportunities for professional growth.
- Other info: Fluency in English; additional European languages are a plus.
- Why this job: Join a mission-driven team that values innovation and collaboration for better healthcare outcomes.
- Qualifications: 10+ years in regulatory roles with strong client-facing experience required.
The predicted salary is between 48000 - 72000 £ per year.
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:
- eCTD/CTD submissions (Modules 1–5)
- 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.
- Offering Development & SOP Ownership
- 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
- Develop and deliver role-based training programs for delivery, sales, project management, and linguist teams:
- Regulatory writing and translation workflows
- Labelling compliance
- HTA dossier language requirements
- Own the creation and rollout of interactive playbooks, job aids, and eLearning modules on regulatory translation best practices.
- Act as mentor and escalation point for linguists and PMs involved in high-complexity, high-risk regulatory or reimbursement projects.
- Cross-Functional Leadership
- Work closely with Delivery, QA, and Solutions teams to implement SOPs and quality checks for high-stakes projects.
- Influence pricing models, scalability assumptions, and resource strategy based on regulatory risk, volume, and market complexity.
- Drive internal knowledge sharing and regulatory intelligence gathering across regions and client accounts.
Experience & Qualifications
Required:
- 10+ years in regulatory, linguistic, or market access roles in life sciences, with extensive client-facing experience.
- Expertise in regulatory labelling, EMA/FDA/HTA submission workflows, and language compliance requirements.
- Demonstrated experience designing SOPs, work instructions, or quality frameworks for regulated content.
- Proven track record in building and delivering internal and external training programs.
- Excellent communication skills with ability to explain regulatory concepts to commercial and operational stakeholders.
Preferred:
- Background in CRO, MAH, regulatory consultancy, or global LSP.
- Knowledge of ISO 17100, 13485, and Veeva RIM or eCTD systems.
- Fluency in English; other European languages are a plus.
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. 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.
SME – Language Solutions for Market Authorization, Labelling & Market Access in Reading employer: IQVIA
IQVIA Language Solutions is an exceptional employer that fosters a culture of innovation and collaboration, making it an ideal place for professionals seeking to make a meaningful impact in the life sciences sector. With a strong commitment to diversity and inclusion, employees are empowered to bring their authentic selves to work, enhancing creativity and driving superior outcomes. The company offers robust training and development opportunities, ensuring that team members grow alongside the evolving landscape of regulatory and market access translation strategies.
StudySmarter Expert Advice🤫
We think this is how you could land SME – Language Solutions for Market Authorization, Labelling & Market Access in Reading
✨Tip Number 1
Familiarise yourself with the latest regulatory guidelines from EMA and FDA. Understanding these frameworks will not only help you in discussions but also demonstrate your commitment to compliance, which is crucial for this role.
✨Tip Number 2
Network with professionals in the life sciences sector, especially those involved in regulatory affairs and market access. Engaging with industry peers can provide insights into current trends and challenges, making you a more informed candidate.
✨Tip Number 3
Prepare to discuss your experience in developing SOPs and training programmes. Be ready to share specific examples of how you've improved processes or enhanced team capabilities in previous roles, as this will be key in showcasing your expertise.
✨Tip Number 4
Stay updated on the latest tools and technologies used in regulatory submissions and multilingual solutions. Familiarity with systems like Veeva RIM or eCTD can set you apart and show that you're proactive about leveraging technology in your work.
We think you need these skills to ace SME – Language Solutions for Market Authorization, Labelling & Market Access in Reading
Some tips for your application 🫡
Understand the Role:Before applying, make sure you fully understand the responsibilities and qualifications required for the Associate Director position. Familiarise yourself with regulatory and market access translation strategies to tailor your application effectively.
Highlight Relevant Experience:In your CV and cover letter, emphasise your 10+ years of experience in regulatory, linguistic, or market access roles. Be specific about your client-facing experience and any expertise in designing SOPs or training programmes.
Showcase Communication Skills:Since excellent communication skills are crucial for this role, provide examples in your application that demonstrate your ability to explain complex regulatory concepts to various stakeholders. This could include past experiences where you successfully led consultations or training sessions.
Tailor Your Application:Make sure to customise your application materials to reflect IQVIA's values and mission. Mention how your diverse experiences and perspectives can contribute to their goal of accelerating innovation for a healthier world.
How to prepare for a job interview at IQVIA
✨Understand Regulatory Requirements
Familiarise yourself with the specific regulatory frameworks relevant to the role, such as EMA and FDA guidelines. Being able to discuss these in detail will demonstrate your expertise and readiness for the position.
✨Showcase Your Client-Facing Experience
Prepare examples of your previous client engagements, particularly those involving high-level consultations. Highlight how you have successfully navigated complex client needs and provided strategic solutions.
✨Demonstrate Training and Mentorship Skills
Be ready to discuss your experience in developing training programmes and mentoring others. This is crucial for the role, so share specific instances where you have built capabilities within teams.
✨Prepare for Cross-Functional Collaboration
Think about how you have worked with various teams in the past, such as QA and project management. Be prepared to explain how you can influence and drive collaboration across different functions to achieve project goals.
