Job Description

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….

ClinChoice is searching for a Regulatory Affairs Associate Consultant for 12 months Contract with possibility of extension to join one of our clients.

ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts.

Job Title

REGULATORY AFFAIRS JR ANALYST Consultant

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.