Regulatory Affairs Officer/Specialist

Regulatory Affairs Officer/Specialist 255

-

-

Regulatory Affairs

We are seeking a highly motivated and detail-oriented Regulatory Affairs Specialist to join our consulting company. The Regulatory Affairs Specialist will be responsible for ensuring compliance with regulatory requirements for the development, approval, and marketing of medical products in Nordics.

Responsibilities

Submission and Approval Process:

• Preparation and submission of Technical/Site Transfer Applications
• Preparation and submission of Marketing Authorisation Applications

Lifecycle Maintenance:

• Preparation and submission of documentation for post-approval applications including, but not limited to, Variations, Renewals, MAH Transfers/COAs, Labeling
• Management of artwork generation, labeling, creation, and update of product information

Compliance:

• Monitor and maintain up-to-date knowledge of Regulatory for DK, FI, IS, NO, SE
• Ensuring compliance with all regulatory processes, in readiness for both internal and external audits
• Ensuring compliance with the regulations of the Nordic agencies (Fimea, DKMA, IMA, NOMA, MPA)

Communication:

• Act as a liaison between the PLG, PLG clients, and the regulatory agencies
• Support internal requests for information

Experience

• 3+ years of relevant experience in DK, FI, IS, NO and SE regulations
• Experience in the management of artwork generation, labeling, creation, update of product information
• Experience with: MLA, MAA, CTD, Variations, Renewals, Labeling, MAH Applications
• Knowledge of the Nordic languages (DK, SE, NO, FI or IS)
• Experience with software packages and databases (Microsoft Office Suite, Veeva Vault (or comparable EDMS), LorenZ, Trackwise, PromoMat etc.)
• Good organizational skills and communication skills
• Ability to prioritize and deliver high-quality work
• Experience in people management/coordination is a plus
• Experience in promotional/non-promotional activities is a plus