Regulatory Affairs Specialist

IQVIA is The Human Data Science Company focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles IQVIA offers a broad range of solutions that harness advances in healthcare information technology analytics and human ingenuity to drive healthcare forward.

Join our dynamic Lifecycle Management team as aRegulatory Affairs Specialist supporting post-approval regulatory activities for human medicinal products in Spain. This is an individual contributor role ideal for professionals with at least 4 years of experience in regulatory affairs on Spanish market.

Key Responsibilities

• Collaborate with local teams to prepare and submit regulatory documents (notifications renewals variations new applications MAH transfers) to local Health Authorities.
• Support the regulatory approval process and ensure compliance with local and international requirements.
• Build and maintain strong relationships with internal stakeholders and external partners.
• Participate in meetings with our clients - global pharmaceutical companies.
• Communicate with Regulatory Agencies.

Qualifications

• Bachelors or Masters degree in Life Sciences or related field.
• Minimum 4 years of experience in post-approval regulatory affairs for Spanish market.
• Solid understanding of AEMPS (Spanish Health Authority) regulatory guidelines. Experience in submissions of new marketing authorizations variations renewals.
• Fluent in English & Spanish.
• Strong organizational and time management skills.
• Proficiency in Microsoft Office.
• Ability to work independently and adapt in a fast-paced environment.

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 .

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.