Senior Regulatory Affairs Specialist (Post Marketing)

As a Regulatory Affairs Specialist you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

The Regulatory Affairs Specialist will be working with drugs' registration according to the local regulatory agencies.

• • Perform all electronic submissions of post-registration requests to ANVISA.
  • Ensure all expected/required correct data is updated/ uploaded in the client’s systems
  • Update change control system (Phenix),
  • Perform the daily and weekly Leaflet monitoring (ANVISA) and request changes on impacted leaflets to client, if applicable.
  • Review and Approve in the client’s system the packaging,  labeling and leaflet materials and follow up as needed.

You are:

• Experience with registration and post-registration regulatory submissions for human health drugs.
• Prior experience using computerized information systems required; experience with PC Windows, word processing, and electronic spreadsheets required.
• Read, write, and speak advanced English; fluent in host country language.

Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.