Associate Director, Regulatory Affairs

IQVIA; Oeiras; Presencial; EUR 150 000 - 190 000; Tempo integral

Resumo da oferta

IQVIA is seeking an experienced Associate Director, Regulatory Affairs to lead complex global regulatory projects for pharmaceutical and biotechnology clients, focusing on strategy, submissions, and health authority interactions.

This client-facing individual contributor role demands strong project leadership, risk management, and cross-functional collaboration across global development programs to deliver compliant regulatory solutions.

Qualificações

• Bachelor's or Master's degree in a life sciences discipline.
• Extensive Regulatory Affairs experience in pharma/biotech/CRO/consulting.
• Experience leading regulatory projects and client engagements.

Responsabilidades

• Serve as Project Lead or Regulatory Lead overseeing multiple projects.
• Develop regulatory strategies to support global development and registration.
• Lead preparation of submission documents (IMPDs, IND meetings, iPSPs/PIPs, fast track designations).
• Coordinate regulatory documentation and compliant submissions (BLA/NDAs/MAA, IND/CTAs).
• Provide strategic regulatory guidance to project teams and clients.
• Act as the regulatory authority contact for assigned projects (FDA/EMA/MHRA).
• Assess regulatory risks and develop mitigation strategies.
• Manage budgets, timelines, and resource planning.

Conhecimentos

Regulatory leadership

Project management

Stakeholder management

Regulatory strategy

Regulatory submissions

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. Learn more at https://jobs.iqvia.com.
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.