Regulatory Affairs Specialist

hace 2 semanas


Colombia Engineeringuk A tiempo completo

**Job Overview:**

We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Engineeringuk. As a key member of our regulatory department, you will be responsible for ensuring compliance with global regulations and guidelines.

**About the Role:**

The successful candidate will have a strong background in pharmaceutical chemistry and experience in regulatory affairs. You will work closely with our cross-functional teams to ensure that our products meet the highest standards of quality and safety.

**Key Responsibilities:**

  • ">
  • Manage activities associated with obtaining initial, amendment, and other central authority approvals.">
  • Perform submission and maintenance of new health records, renovations, and modifications.">
  • Prepare and attend meetings with INVIMA (MoH) and/or the entity designated by the Government.">
  • Review promotional materials for products in Veeva Vault or current tool.">
  • Perform submission and monitoring of products in procedures such as PSUR, DSUR, RMPs, and safety information.">

**Requirements:**

To be successful in this role, you will need:

  • ">
  • Bachelor's Degree in Pharmaceutical Chemistry.">
  • Technical knowledge in the preparation of a dossier.">
  • Previous experience in the regulatory area (minimum 1 year).">
  • Knowledge of current ICH and local regulations.">
  • Prior experience using computerized information systems.">
  • Proficiency in English and host country language.">

**What We Offer:**

We offer a competitive salary of **£45,000-£60,000 per annum**, depending on experience, plus a range of benefits including:

  • ">
  • A comprehensive health insurance plan.">
  • A generous pension scheme.">
  • A flexible working arrangement.">
  • Ongoing training and development opportunities.">

**Why Choose Us:**

We are a dynamic and innovative company that values diversity, inclusion, and belonging. We are committed to providing an inclusive and accessible environment for all employees. We believe that everyone deserves equal opportunities, regardless of their background, age, gender, ethnicity, disability, or any other characteristic.



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