Regulatory Affairs Specialist, IQVIA Biotech

IQVIA; Oeiras; Presencial; EUR 40.000 - 70.000; Tempo integral

Resumo da vaga

IQVIA in Portugal is seeking a Regulatory Affairs professional to join our Biotech Regulatory Affairs team, supporting clinical research projects across Europe. You will provide regulatory expertise and hands-on support throughout clinical development, with a focus on EU CTR submissions, working within a global project-based team on drug development programs including chemical entities and biologics.

This role offers ownership of regulatory activities within assigned projects and opportunities

Qualificações

• Bachelor’s degree in a scientific field or equivalent.
• At least 3 years of Regulatory Affairs or related experience.
• Hands-on EU CTR submission experience.
• Good understanding of European clinical trial regulatory requirements and GCP.
• Experience reviewing clinical and regulatory documentation.

Responsabilidades

• Take regulatory responsibility for assigned clinical research projects, providing regulatory guidance and operational support.
• Independently prepare and complete EU CTR submissions on time.
• Interpret and apply regulations, guidelines and regulatory agency requirements.
• Review protocols, reports and other clinical/regulatory documents for compliance.
• Support regulatory authority interactions, communications and submissions.
• Compile and manage regulatory documentation for projects.

Conhecimentos

EU CTR submissions

Regulatory guidance

Cross-functional teams

Bachelor's degree

Formação

Bachelor's degree

Descrição da vaga

We are looking for a Regulatory Affairs professional to join our IQVIA Biotech Regulatory Affairs team, supporting clinical research projects across Europe.

In this role, you will provide regulatory expertise and hands-on support throughout clinical development, with a particular focus on EU Clinical Trials Regulation (EU CTR) submissions. You will work as part of a global, project-based team supporting primarily drug development programs, including chemical entities and biologics.

This is a great opportunity for someone who already has practical EU CTR submission experience and is ready to take ownership of regulatory activities within assigned projects.

What you will be doing

• Take regulatory responsibility for assigned clinical research projects, providing regulatory guidance and operational support to project teams.
• Independently prepare and complete EU CTR submissions, ensuring regulatory requirements and timelines are met.
• Interpret and apply relevant regulations, guidelines and regulatory agency requirements.
• Review protocols, reports and other clinical and scientific documentation for regulatory compliance.
• Support regulatory authority interactions, communications and submissions.
• Compile, maintain and manage regulatory documentation required for assigned clinical research projects.
• Provide regulatory input and guidance to cross-functional project teams.
• Support primarily drug development programs, including chemical entities and biologics.
• Contribute to broader Regulatory Affairs activities and cross-functional initiatives as required.

What we are looking for

Essential:

• Bachelor’s degree, ideally in a scientific or related discipline, or an equivalent combination of education and relevant experience.
• At least 3 years of relevant professional experience within Regulatory Affairs, clinical research or a closely related area.
• Hands-on EU CTR submission experience, with the ability to manage and complete submissions independently.
• Good understanding of European clinical trial regulatory requirements and Good Clinical Practice.
• Experience reviewing and working with clinical and regulatory documentation.
• Strong analytical skills and the ability to interpret complex regulatory information.
• Excellent written and verbal communication skills.
• Strong attention to detail and the ability to work effectively within cross-functional and international project teams.

Nice to have:

• Regulatory experience outside Europe, for example North America.
• Experience working with biologics.
• Previous CRO and/or pharmaceutical/biotech industry experience.
• Knowledge of medical-device regulatory requirements.

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.