Coripharma ehf.

Coripharma er nýsköpunarfyrirtæki í Hafnarfirði sem þróar og framleiðir samheitalyf fyrir önnur lyfjafyrirtæki á erlendum mörkuðum. Frá því að félagið hóf starfsemi árið 2018 hefur það vaxið hratt og undirbýr nú útflutning á tugum lyfja. Í dag starfa um 190 manns hjá Coripharma. Nánari upplýsingar um Coripharma má finna á www.coripharma.is

Про

Regulatory Affairs Associate

Regulatory Affairs is a part of the R&D Operations at Coripharma. The Regulatory Affairs team ensures that Coripharma products, processes, and documentation adhere to regulatory standards and laws, such as those set by the EMA (European Medicines Agency) in Europe, or other local authorities. The team manages submissions of regulatory dossiers to obtain approval of marketing authorizations. This includes preparing and filing applications, as well as providing responses to regulatory authorities acting as a liaison between the company and regulatory authorities, responding to queries, and providing regular updates to ensure ongoing compliance.

Regulatory affairs associate supports the Regulatory Affairs team in maintaining regulatory compliance by performing administrative tasks, managing documents, and assisting in the preparation and submission of regulatory filings.

Helstu verkefni og ábyrgð

Provide administrative support to the regulatory affairs team, including but not limited to:
Scheduling meetings, preparing agendas, and taking minutes
Preparation and review of regulatory documents and submissions
Assist in the compilation and submission of regulatory documents to health authorities
Maintain regulatory files and databases
Communicate regulatory requirements and updates to internal teams.
Liaise with other departments (e.g., R&D, Quality, Clinical) to ensure regulatory requirements are met.
Planning and coordinating internal and external audits.
Support cross-functional teams in regulatory-related activities

Menntunar- og hæfniskröfur

Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, or a related field is preferred.
Experience in regulatory affairs or a related administrative role in the pharmaceutical, biotechnology, or medical device industry is preferred
Basic understanding of regulatory requirements and guidelines (e.g., FDA, EMA, ICH). Familiarity with regulatory submission processes and documentation is a plus.
Strong organizational and administrative skills.
Excellent written and verbal communication skills.
Ability to work independently and as part of a team.
Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint)