Senior Regulatory Affairs Specialist

hace 4 meses

Colombia Huila ICON A tiempo completo

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

The Senior Regulatory Affairs Associate has responsibility for providing comprehensive regulatory services to clients within the pharmaceutical, biologic, medical device or other regulatory services environments. This will include support for assessment, registration, maintenance and other activities as assigned.

You will be partnering with a pharmaceutical company committed to discovering and developing treatments that improve and save people´s lives. Working in this program you will feel challenged and supported to advance in your professional career while making a truly impact.

**What you will be doing**:
The Regulatory Affairs Specialist will be working with drugs' registration according to the local regulatory agencies.
- Perform all electronic submissions of registration and post-registration requests to regulatory agencies.
- Ensure all expected/required correct data is updated/ uploaded in the systems (Veeva)
- Supports assigned teams in the preparation of all submission types in adherence with applicable legislation, regulations and guidelines facilitating approvals and continued client compliance.
- Maintains a positive and productive liaison with internal and external contacts. This may include clients, regulatory agencies, and related institutions.
- Assists in the development of assessments and strategic regulatory plans for client product development programs.
Supports the development of initial or alternative strategies, consulting with their manager or other resources within the organization.

**You are**:

- Bachelor’s degree in a health, life sciences or other relevant field of study.
- Experience with registration and post-registration regulatory submissions for human health drugs (South and Central America)
- 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.

**Why 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.

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.

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, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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