We are looking for a Junior International Regulatory Affairs Technician to develop and organize regulatory strategies and implementation plans for the preparation and submission of new products as well as the maintenance of the current portfolio, for the assigned International Business countries.
Si está considerando enviar una solicitud, asegúrese de pulsar el botón de solicitar de abajo después de leer la descripción completa.
This role is an excellent opportunity for someone seeking to continue a career in International Regulatory Affairs within a technical, multicultural, and highly collaborative environment.
Responsibilities
* Prepare, compile and maintain the registration dossiers for pharmaceuticals, cosmetics, medical devices, food supplements, and other products in international markets.
* Adapt technical and administrative documentation according to the requirements provided by local regulatory partners or agents.
* Act as the operational point of contact with regulatory partners or agents in each country.
* Channel regulatory requests, comments, and requirements received from agents.
* Coordinate the submission of technical and administrative documentation to partners within established deadlines.
* Follow up on the status of regulatory procedures through partners or regulatory agents.
* Keep international regulatory files organized and up to date.
* Control versions of dossiers, packaging materials, leaflets, and certificates.
* Manage databases of regulatory registrations, expiry dates, and renewals.
* Coordinate legalizations, apostilles, and technical translations required by destination countries.
* Request and collect required information from technical departments, Marketing, and/or the International Business area.
* Coordinate internal timelines to meet planned product launch schedules.
Requirements
* Bachelor’s Degree in Pharmacy, Chemistry, Biology or a related Life Sciences/Scientific field.
* Master’s in a pharmaceutical industry or Postgraduate degree in Regulatory Affairs.
* Minimum of 2 years of experience as a Regulatory Affairs Technician in International Regulatory Affairs.
* Fluency in English and Spanish (spoken and written), other languages are a plus.
* Ability to work with detailed technical information.
* Ability to work independently in fast-paced environment.
* Solid knowledge of Microsoft Office and digital tools.
* Excellent organization, accuracy, and written communication skills. xsgfvud
We Offer
* Permanent position
* Flexible schedule
* Benefits Package
* Life insurance
If you meet these requirements, we are looking forward to meeting you!
Applying to this job opening, you consent to LACER, S.A. processing your personal data for the purpose of assessing your candidacy. You may consult our privacy policy and learn how to exercise your rights of access, rectification, erasure, restriction, portability, and objection at the following link: "