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Regulatory Affairs Specialist

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Kuala Lumpur, Kuala Lumpur, Malaysia IQVIA Argentina Full time

We are looking for a skilled Regulatory Affairs Specialist - Clinical Research to join our cFSP team at IQVIA Argentina. As a key member of the team, you will be responsible for ensuring compliance with regulatory requirements and maintaining high-quality documentation. You will possess a strong background in clinical research, with experience in regulatory affairs and study start-up activities.

The ideal candidate will have excellent interpersonal skills, with the ability to communicate effectively with cross-functional teams. They should also have a thorough understanding of regulated clinical trial environments and be proficient in using systems and technology to achieve work objectives.

Responsibilities:

  1. Collaborate with cross-functional teams to develop and implement effective regulatory strategies.
  2. Prepare and submit high-quality regulatory documents and applications.
  3. Conduct regular audits and inspections to ensure compliance with regulatory requirements.
  4. Develop and maintain relationships with regulatory agencies and stakeholders.
  5. Provide training and support to colleagues on regulatory requirements and best practices.
  6. Stay up-to-date with changes in regulatory guidelines and legislation.

About Us:

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.