Associate Director, Regulatory Affairs

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 is seeking 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, regulatory submissions, project leadership, and health authority interactions across global development programs.

What You'll Do

• Serve as the Project Lead or Regulatory Lead and oversee multiple regulatory projects simultaneously, ensuring delivery of high-quality outcomes on schedule and within budget.
• Develop regulatory strategies to support global clinical development and product registration objectives.
• Lead the preparation and compilation of submission documents, including Investigational Medicinal Product Dossiers (IMPDs), Investigational New Drug (IND) meeting request letters and briefing packages, Scientific Advice packages, iPSPs/PIPs, Orphan Drug Designation, Fast Track Designation, and Accelerated Approval, and ensure appropriate incorporation into the regulatory strategy.
• Partner with regulatory publishing and operations to coordinate, review, and support preparation of regulatory documentation and compliant submissions including BLA/NDAs/MAA, IND/CTAs and supplements.
• Provide strategic regulatory guidance to project teams, clients, and cross-functional stakeholders.
• Serve as the point of contact with regulatory authorities for assigned projects.
• Support Scientific Advice procedures and health authority interactions with the FDA, EMA, and MHRA (and national competent authorities), meeting strategy, and follow-up.
• Assess regulatory risks and develop mitigation strategies to support successful project execution.
• Manage project budgets, timelines, resource planning, and client expectations.
• Collaborate with multidisciplinary teams to deliver regulatory solutions across global programs.
• Develop contingency plans, with associated risks and mitigation strategies to achieve regulatory objectives

What We're Looking For

• Bachelor's or Master's degree in a life sciences discipline.
• Extensive Regulatory Affairs experience within pharmaceutical, biotechnology, CRO, or consulting environments.
• Demonstrated experience leading regulatory projects and client engagements.
• Strong understanding of clinical development and regulatory submission pathways.
• Experience with IND, CTA submissions and health authority interactions.
• Experience supporting IND submissions is preferred.
• Knowledge of FDA, EMA, and international regulatory requirements.
• Strong project management, organizational, and stakeholder management skills.
• Ability to manage multiple priorities in a fast-paced consulting environment.
• Experience managing project budgets and resource planning.
• Excellent written and verbal communication skills in English.
• Preferred Experience across both EU and US regulatory environments.
• Experience supporting global regulatory development programs.
• Additional language capabilities are welcomed.
• Familiarity with AI-enabled productivity tools and modern digital ways of working.

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.

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

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.

Likewise, as part of this culture, IQVIA is committed to ensuring effective equality between women and men, integrating it as a strategic principle in its corporate and human resources policies.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries.

We create connections that accelerate the development and commercialization of innovative medical treatments.

Everything we do is part of a journey to improve patient outcomes and population health worldwide.

To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact.

No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere.

Thank you for your interest in growing your career with us.