Associate Director, Regulatory Affairs

IQVIA · Porto Salvo, Portugal

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RegulatoryFull-timeCompany career page

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Role summary

IQVIA seeks an experienced Associate Director to lead regulatory projects for pharmaceutical and biotech clients across global development programs. The role involves developing regulatory strategies, managing submissions (INDs, NDAs, MAAs), coordinating health authority interactions, and overseeing project timelines and budgets. Candidates should hold a life sciences degree and demonstrate extensive regulatory affairs experience with proven project leadership in clinical development and submission pathways.

What they're looking for

Bachelor's or Master's degree in life sciences discipline
Extensive regulatory affairs experience in pharmaceutical or biotechnology environments
Demonstrated project leadership and client engagement experience
Strong understanding of clinical development and regulatory submission pathways
Experience with IND and CTA submissions and health authority interactions
Knowledge of FDA, EMA, and international regulatory requirements
Project management and stakeholder management skills

What you'll be doing

Lead multiple regulatory projects simultaneously as project lead, ensuring quality outcomes within budget and timeline
Develop regulatory strategies supporting global clinical development and product registration
Prepare and compile submission documents including IMPDs, INDs, Scientific Advice packages, and BLA/NDAs/MAAs
Serve as point of contact with regulatory authorities including FDA, EMA, and MHRA
Manage project budgets, timelines, resource planning, and client expectations

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Date posted24 days ago

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