Regulatory Affairs Associate Consultant (Colombia)

at  ClinChoice

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 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.

EDUCATION AND EXPERIENCE:

• 5+ years of relevant experience with BSc in Pharmacy or related health sciences.
• Must have knowledge of regulations for Cosmetics in Andean Markets (Columbia, Ecudor, Peru, etc).
• Language: English is required.
• Portuguese is desirable.
• Strong working knowledge of Microsoft Word, Excel, Power Point
• Good communication and follow-up skills with country regulatory liaisons for clear understanding of country specific needs for registrations, license updates and import/export requirements.

• Preparation, compilation, and coordination of high-quality regulatory submissions for new product launches, product updates, and throughout the product lifecycle.
• Support coordination of label change initiation, label reviews and changes in accordance with regional /country review system and procedure.
• Provide regulatory input, review and approval related to change control.
• Support product portfolio through execution of legal document activities as required.
• Preparation and compilation of regulatory documentation for submission
• Develop and manage regulatory action item tables for country-specific requirements.
• Work with client regulatory managers to develop project implementation plans and manage workload planning to ensure on-time completion of projects and tasks.
• Support client regulatory managers in their registration procedure.
• Provision of weekly updates (at a minimum) to relevant client regulatory managers
• Ensure regulatory standards and timelines are met.
• Plan and track the status of ongoing regulatory projects.
• Regulatory action item tables for country-specific requirements and importation/ exportation needs for change in legal entity.
• Ensuring documents for health authority are submission ready.
• Supporting coordination of label change initiation, label reviews and changes in accordance with regional /country review system and procedure.
• Regulatory input, review and approval related to Change Control.