Snr Reg Affairs officer

Snr Reg Affairs officer

RESPONSIBILITIES

• Develop high-quality Clinical trial content for Regulatory Intelligence including expert summary generation and cross-country tables.
• In-depth knowledge on clinical trial regulatory including:
  • Requirements in all phases of drug development (phase I-IV studies)
  • Clinical trial applications and ethics committees
  • Regulatory processes and approval times
  • Knowledge on clinical trial registries and results disclosed.
  • Ability to assess impact of new regulatory requirements.
  • Compassionate Use/Expanded Access programs
•  Ability to assess and anticipate impact of new regulatory requirements on clinical trials.

• Works within cross-functional teams and collaborates with a network of internal/external regulatory experts to ensure the production and maintenance of high-quality (timeliness, completeness, and accuracy) regulatory intelligence content related to Clinical trials content.

• Perform quality control checks on contributions from external experts related to Clinical trials content.
• Acts as a Subject Matter Expert (SME) in regulatory knowledge for Clinical trials.
• Manage workload effectively by understanding the scope of work and deliverables, ensuring timely and accurate outcomes.
• May give guidance to colleagues, including feedback on the quality of technical documents, and may assist in their training and development.
• May conduct and present regulatory training sessions for small groups or individuals within the Regulatory Intelligence team.

REQUIRED KNOWLEDGE, SKILLS, AND ABILITIES

• In-depth understanding of regulatory requirements and guidelines for Clinical trials, including those from the FDA, EMA, and other international regulatory bodies.
• Ability to understand and interpret regulatory developments (guidelines, regulations, and laws) to understand, anticipate, interpret, and communicate regulatory trends and requirements.
• Minimum 5 years of relevant experience in Clinical trials

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.

Experience Level

Mid Level