REGULATORY AFFAIRS JR ANALYST Consultant

Job Title

REGULATORY AFFAIRS JR ANALYST Consultant

Job Summary

Ensures regulatory data is compliant in all databases. Execute activities such as preparation of labels, update of systems and archives, review regulatory data in internal and external databases. Support submission and approvals of market licenses including changes, renewals and establishment registrations. Organize and balance a multitude of activities simultaneously.

Scope

Major  Roles and Responsibilities

• Execute post-approval activities such as review of databases, preparation of communications to stakeholders.
• Update systems with regulatory data and documents.
• Review labels compliance in internal system.
• Execute submission of changes, amendments, rectifications and renewals in timely manner with guidance.
• Provide assistance with establishment registration licenses.
• Request and follow-up of documentation to prepare registration dossiers.
• Supports regional team on product submissions schedules, prioritization, and pipeline management with guidance.
• Act as a point of contact for stakeholders to support business plans and regulatory needs.
• Support projects as representative of the subject/country.
• Organize the archive of the area.
• Organize team meetings and elaborate agenda and minutes.
• Support compulsory certification activities.

Competencies

• Planning and Organizing skills
• Analytical capability and investigative skills
• Prioritizes work to meet deadlines

• Understands the importance of the adherence to compliance
• Ability to manage complex data with excel spreadsheets are desirable

GLP Behaviors

• Collaboration and teaming
• Intellectual curiosity
• Sense of Urgency

·       Accountability

·       Integrity & Credo-based Actions

• Self Awareness & Adaptability

Experience/ Qualification  Requirements

• Desirable some experience working in Regulatory Environment (and/or training or equivalent combination of education and experience), preparing submissions for Colombian Health Authorities.

·       Desirable experience in health care companies.

Education Requirements

·       A Bachelor’s Degree in Engineering, Pharmacy or other life science: Can be a person with related experience and/or training or equivalent combination of education and experience. Intermediate writing and reading skills in English.