Product Registration Technician

at  Curaleaf

Alcochete, Área Metropolitana de Lisboa, Portugal -

Start DateExpiry DateSalaryPosted OnExperienceSkillsTelecommuteSponsor Visa
Immediate04 Dec, 2024Not Specified04 Sep, 2024N/ATraining,Timelines,Pharmaceutical Industry,Regulatory Requirements,Project Management Skills,English,Manufacturing ProcessesNoNo
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Description:

AT CURALEAF INTERNATIONAL, WE’RE NOT JUST PARTICIPATING IN THE CANNABIS INDUSTRY—WE’RE LEADING IT.

As part of the world’s largest cannabis company, Curaleaf Holding, Inc., we are powered by a strong presence at all stages of the supply chain. Our unique distribution network throughout Europe, Canada and Australasia brings together pioneering research with cutting-edge cultivation, extraction, and production. Amidst a rapid growth trajectory, our emphasis on quality and expertise aims to deliver safe and legal cannabis.
Curaleaf International’s subsidiary network includes Curaleaf Clinic, Curaleaf Pharmacy, and Curaleaf Laboratories within the UK; Terra Verde cultivation facility in Portugal; Medalchemy research and development site in Spain; Four20 Pharma wholesaler and distributor in Germany; Northern Green Canada the EU-GMP producer; and the Polish wholesaler Can4Med.
Our Vision: To shape the future of cannabis through our commitment to research and product excellence
Our Mission: To be the world’s leading cannabis company consistently delivering superior products and services and driving the global acceptance of cannabis.

REQUIREMENTS

  • BSc/MSc or equivalent in a discipline related to the pharmaceutical industry.
  • Training and experience in the Regulatory Affairs pharmaceutical sector.
  • Deep knowledge of pharmaceutical manufacturing processes (EU-GMPs), regulatory requirements, and quality control procedures.
  • Experience in a Chemistry Manufacturing and Controls (CMC) role would be preferred.
  • Understanding of the current medicinal cannabis regulatory frameworks around Europe would be preferred.
  • Attention to detail and extremely well-organized person.
  • Project management skills. Comfortable working on multiple projects in parallel.
  • Ability to set priorities, resources, goals, and timelines.
  • Regulatory writing knowledge.
  • Good problem-solving skills.
  • Fluent in English. Spanish/Portuguese would be a plus.

Responsibilities:

OVERVIEW OF ROLE:

Working in the central Regulatory team, reporting to the Head of Regulatory Affairs, you will manage the aspects related with submissions of regulatory documents (CTDs) to Authorities to obtain Marketing Authorizations (MA) for cannabis-based products (substances, preparations, and medicines) for medicinal purpose. Your role will also involve prioritizing activities and adjusting to meet timelines while communicating cross-functionally. An example of cross-functionality would be the interactions with the Curaleaf International group to obtain the necessary technical information for the MA applications.

RESPONSIBILITIES:

  • Prepare the required administrative and technical documentation for MA applications (CTD format) or product registration in different jurisdictions (Europe and others).
  • Coordinate activities between the quality/regulatory teams in every country so the needed information is prepared with the required quality and delivered in a timely manner.
  • Manage all the activities related with the process of dossier submission. Interactions with local consultants and/or authorities.
  • Manage the procedures, whenever needed, with local Authorities.
  • Other internal Regulatory tasks as assigned.


REQUIREMENT SUMMARY

Min:N/AMax:5.0 year(s)

Pharmaceuticals

Pharma / Biotech / Healthcare / Medical / R&D

Clinical Pharmacy

MA

Proficient

1

Alcochete, Portugal