Director of Regulatory Affairs

QTC are partnered with an international pharmaceutical company with expanding operations across Europe in seeking an experienced Regulatory Affairs Director to support and drive EU/UK regulatory activities. The organization has a strong presence across Asian and global markets and is continuing to build its European commercial and regulatory footprint.

This is a high-visibility individual contributor role for a senior regulatory professional who can serve as the local regulatory contact point for European authorities, while partnering closely with international headquarters and cross‑functional global teams. The position is ideal for someone who enjoys strategic regulatory ownership, hands‑on submission management, and operating within an entrepreneurial, internationally expanding environment.

Key Responsibilities:

Develop and execute EU/UK regulatory strategies for pharmaceutical products across development and lifecycle stages

Act as the primary local contact point for regulatory agencies including EMA, MHRA, and EU competent authorities

Lead and coordinate regulatory submissions including MAAs, CTAs, variations, renewals, and scientific advice packages

Ensure maintenance and lifecycle management of existing product registrations across European markets

Provide regulatory guidance to internal global stakeholders across CMC, clinical, quality, and commercial functions

Assess regulatory risks and propose mitigation strategies to support timely approvals and compliance

Collaborate closely with international teams to ensure high‑quality dossiers and successful submissions

Track evolving EU/UK regulatory requirements and evaluate impact on company portfolio and strategy

Support regulatory communications, agency correspondence, and inspection readiness activities as required

Candidate Profile:

10+ years of pharmaceutical regulatory affairs experience

Strong expertise in EU regulatory procedures and submission pathways (MRP/DCP/CP)

Proven experience with CTD/eCTD submissions and lifecycle management activities

Hands‑on experience interacting with EMA, MHRA, and/or European competent authorities

Ability to operate independently in a senior individual contributor capacity

Strong understanding of EU regulatory strategy and post‑approval maintenance activities

Excellent stakeholder management and cross‑cultural communication skills

Experience with in generics, specialty pharma, injectables, or oncology is advantageous

Experience working with Asian/global headquarters or international matrix organizations is highly preferred

Why Join:

Opportunity to play a key role in a growing international pharmaceutical business

High level of ownership and visibility within European operations

Exposure to global regulatory strategy and cross-border collaboration

Dynamic and entrepreneurial working environment with international growth ambitions

Competitive compensation package and long‑term development potential

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