Regulatory Affairs Specialist Oeiras

Regulatory Affairs Specialist
Oeiras
Oeiras, Distrito de Lisboa, Portugal

Join to apply for the Regulatory Affairs Specialist role at IQVIA

Join to apply for the Regulatory Affairs Specialist role at IQVIA

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.

Regulatory Affairs Specialist – EU & Global Markets

Language: Fluent English required

Join our dynamic Lifecycle Management team as a Regulatory Affairs Specialist supporting
- approval regulatory activities for human medicinal products across the EU and global markets. This is an individual contributor role ideal for professionals with at least 4 years of experience in EU regulatory affairs.

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.
• Draft
  - quality regulatory and technical documentation with minimal supervision.
• Build and maintain strong relationships with internal stakeholders and external partners.
• Contribute to the development and revision of regulatory SOPs.
• Participate in meetings with Regulatory Agencies and support communication strategies.
  
  

Qualifications

• Bachelor’s or Master’s degree in Life Sciences or related field.
• Minimum 4 years of experience in
  - approval regulatory affairs for the EU market.
• Fluent in English (C1 or above).
• Solid understanding of the R&D process (especially CMC), EU regulatory guidelines, and submission procedures.
• Strong organizational and time management skills.
• Proficiency in Microsoft Office and regulatory publishing tools.
• Ability to work independently and adapt in a
  - 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 https://jobs. iqvia.com

Seniority level

• Seniority level

  Not Applicable

Employment type

• Employment type

  Full-time

Job function

• Job function

  Legal

• Industries

  Pharmaceutical Manufacturing

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