Global Regulatory Strategy Lead

IQVIA LLC; Porto; Híbrido; EUR 90 000 - 130 000; Tempo integral

Resumo da oferta

IQVIA LLC in Porto seeks an experienced Associate Director, Regulatory Affairs to lead complex global regulatory projects for pharmaceutical and biotechnology clients. This is a client-facing individual contributor role focused on regulatory strategy, submissions, project leadership, and health authority interactions.

You will guide global development programs, prepare and compile submission documents (INDs, CTAs, BLAs, MAAs), manage budgets and timelines, and act as the primary contact with

Qualificações

• Bachelor's or master's degree in life sciences.
• Extensive regulatory affairs experience in pharma/biotech/CRO/consulting.
• Experience leading regulatory projects and client engagements.
• Strong understanding of clinical development and regulatory submission pathways.

Responsabilidades

• Lead multiple regulatory projects as Project Lead/Regulatory Lead, ensuring timely, high-quality deliverables within budget.
• Develop regulatory strategies to support global clinical development and product registration objectives.
• Prepare and compile submission documents (IMPDs, IND/meeting requests, briefing packages, Scientific Advice, iPSPs/PIPs, Orphan/ Fast Track/ Accelerated paths).
• Coordinate submissions (BLA/NDAs/MAA, IND/CTAs and supplements) with regulatory publishing and operations.
• Provide strategic regulatory guidance to project teams, clients, and cross-functional stakeholders.
• Serve as the primary contact with regulatory authorities for assigned projects.
• Support health authority interactions (FDA, EMA, MHRA) and meeting strategy.
• Assess regulatory risks and develop mitigation plans for project success.
• Manage budgets, timelines, resources, and client expectations.
• Collaborate with multidisciplinary teams to deliver regulatory solutions across global programs.
• Develop contingency plans with risk mitigation to meet objectives.

Conhecimentos

Regulatory leadership

Regulatory strategy

Project management

Client engagement

English communication

Formação académica

Bachelor's or Master's in life sciences

Descrição da oferta de emprego

IQVIA LLC in Porto seeks an experienced Associate Director, Regulatory Affairs to lead complex global regulatory projects for pharmaceutical and biotechnology clients. This is a client-facing individual contributor role focused on regulatory strategy, submissions, project leadership, and health authority interactions.

You will guide global development programs, prepare and compile submission documents (INDs, CTAs, BLAs, MAAs), manage budgets and timelines, and act as the primary contact with