Regulatory Affairs Manager - Nordics

Blackfield Associates; Denmark; On-site; GBP 65,000 - 90,000; Full time

Job summary

Blackfield Associates seeks a Regulatory Affairs Manager to lead Nordic regulatory activities across the UK and Nordic markets. You will join an established European Regulatory Affairs team, acting as the local regulatory expert for Denmark, Sweden and Finland, handling submissions, lifecycle activities, and compliance tasks.

The role requires 4-5+ years in Regulatory Affairs within pharma, with hands-on Nordic experience and strong knowledge of local processes.

Qualifications

• 4-5+ years' Regulatory Affairs experience within pharmaceutical products.
• Hands-on experience supporting Nordic markets, particularly Denmark, Sweden and/or Finland.
• Strong knowledge of local regulatory processes, authority portals and submission systems.
• Experience with lifecycle management, local submissions, artwork, labelling and leaflet management.
• Understanding of VNR numbers, leaflet uploads and shortage notification requirements.
• Nordic language skills sufficient to review local-language regulatory materials.
• Able to work independently as the local regulatory expert.
• Wider EU regulatory experience would be advantageous.
• Contractors seeking a move into a permanent position are encouraged to apply.

Responsibilities

• Lead day-to-day Regulatory Affairs activities across Nordic markets.
• Manage lifecycle maintenance, local submissions and regulatory notifications.
• Review and maintain artwork, labelling and patient information leaflets.
• Upload and maintain product information within local regulatory databases.
• Manage VNR numbers and local product-information requirements.
• Monitor regulatory changes and provide regulatory intelligence to the wider team.
• Support shortage notifications and local market compliance activities.
• Coordinate English-only and country-specific labelling applications where required.
• Collaborate with European regulatory colleagues and support wider EU activities and due diligence projects where appropriate.

Skills

Regulatory Affairs

Nordic markets

Independent worker

EU regulatory

Job description

A growing pharmaceutical services organisation is looking to hire a Regulatory Affairs Manager to support its regulated pharmaceutical business across the Nordic region. Working alongside an established European Regulatory Affairs team, you will act as the local regulatory expert for Nordic markets, managing submissions, product lifecycle activities, artwork and country-specific compliance requirements.

Location: UK, Denmark, Sweden or Finland

Type: Permanent

Key Responsibilities

• Lead day-to-day Regulatory Affairs activities across Nordic markets.
• Manage lifecycle maintenance, local submissions and regulatory notifications.
• Review and maintain artwork, labelling and patient information leaflets.
• Upload and maintain product information within local regulatory databases.
• Manage VNR numbers and local product-information requirements.
• Monitor regulatory changes and provide regulatory intelligence to the wider team.
• Support shortage notifications and local market compliance activities.
• Coordinate English-only and country-specific labelling applications where required.
• Collaborate with European regulatory colleagues and support wider EU activities and due diligence projects where appropriate.

Requirements

• 4-5+ years' Regulatory Affairs experience within pharmaceutical products.
• Hands-on experience supporting Nordic markets, particularly Denmark, Sweden and/or Finland.
• Strong knowledge of local regulatory processes, authority portals and submission systems.
• Experience with lifecycle management, local submissions, artwork, labelling and leaflet management.
• Understanding of VNR numbers, leaflet uploads and shortage notification requirements.
• Nordic language skills sufficient to review local-language regulatory materials.
• Able to work independently as the local regulatory expert.
• Wider EU regulatory experience would be advantageous.
• Contractors seeking a move into a permanent position are encouraged to apply.

This is an excellent opportunity to join a growing business where you can take ownership of Nordic regulatory activities while gaining exposure to wider European regulatory projects and due diligence initiatives.