Local Regulatory Affairs Manager at Actriv Healthcare

Oslo, Oslo, Norway

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Pharmaceuticals, Personal CareIndustries

Requirements

University degree in Life Science
Solid understanding of regulatory requirements and legal frameworks in Norway
Minimum 5 years of experience in Pharmaceuticals (experience in other classifications appreciated but not necessary)
Experience with artwork maintenance and label requirements
Strong cross-functional collaboration across Scientific Affairs, Operations, Commercial, and external stakeholders
Solid working relationship/experience with regulatory authorities (experience with Norwegian authorities is a plus)
Fluent in Norwegian and English
Strong communicator, both written and verbal
Proactive, service-minded, and solutions-oriented
Commercially aware, with a business-driven approach to regulatory challenges
Flexible, open-minded, and collaborative, with the ability to see the big picture and challenge the status quo
Highly diligent, trustworthy, and skilled at prioritizing and driving tasks independently

Responsibilities

Ensure timely planning, preparation, submission and follow-up of regulatory activities in Norway across all classifications
Life cycle management of Pharma products
Handle communication with different authorities as needed
Reviewing AW’s and, as needed, commercial material
Lead local projects from a Regulatory Affairs perspective, connecting across functions and markets
Give key input on market access for various products
Oversee local roll-out of Global NPDs/EPDs/GeoX projects
Smart risk assessment to balance commercial needs and compliance
Secure compliance in Veeva RIM system and GLAMS AW system (artwork)
Ensure product information, translations, and artwork meet regulatory requirements
Keep national databases and product monograph websites updated
Partner closely with Global RA for alignment on globally managed products present in Scandinavia

Skills

Key technologies and capabilities for this role

Regulatory AffairsPharma Lifecycle ManagementRegulatory SubmissionsAuthority CommunicationCompliance ReviewCommercial Material ReviewCross-functional CollaborationNorway Regulations

Questions & Answers

Common questions about this position

What is the work arrangement for this role?

The position is hybrid and based in the office in Oslo, Norway.

What qualifications are required for this position?

Candidates need a university degree in Life Science, solid understanding of regulatory requirements and legal frameworks in Norway, and minimum 5 years of experience in Pharmaceuticals.

What is the salary or compensation for this role?

This information is not specified in the job description.

What is the company culture like at Karo Healthcare?

Karo Healthcare is a dynamic and growing company with a fast-paced, international environment that emphasizes regulatory excellence, commercial growth, collaboration across functions, and career growth opportunities.

What makes a strong candidate for this Local Regulatory Affairs Manager role?

A structured and collaborative RA professional with a Life Science degree, deep knowledge of Norwegian regulations, and at least 5 years in Pharmaceuticals who thrives in fast-moving environments will stand out.

Actriv Healthcare

Connects healthcare facilities with nursing professionals

About Actriv Healthcare

Actriv Healthcare connects healthcare facilities with nursing professionals through a digital platform designed for healthcare staffing. The platform allows nursing professionals to create their own schedules, select preferred workplaces, and contribute to patient care. Users download the Actriv app, complete their application, upload credentials, and schedule an interview. Once approved, they can choose shifts that fit their availability, clock in and out for work, and receive payment, along with benefits like vacation and sick time. Actriv stands out from competitors by emphasizing flexibility in work schedules and leveraging technology to streamline the staffing process. The company's goal is to enhance patient care by providing healthcare facilities with the staffing solutions they need while offering nursing professionals the flexibility they desire.

Tacoma, WashingtonHeadquarters

2017Year Founded

$243.2KTotal Funding

DEBTCompany Stage

HealthcareIndustries

51-200Employees

Benefits

Professional Development Budget

Risks

Rising competition from similar healthcare staffing platforms threatens market share.

AI-driven staffing solutions may reduce need for traditional platforms like Actriv.

Potential labor law changes could impact Actriv's business model.

Differentiation

Actriv offers a unique platform for flexible nursing work schedules.

The company provides a seamless app experience for healthcare professionals.

Actriv's platform emphasizes matching skilled professionals with patient care needs.

Upsides

Actriv secured $3.9M for expansion in Tacoma, boosting growth potential.

Four-year streak on Inc. 5000 highlights Actriv's rapid growth and success.

Increased demand for flexible work aligns with Actriv's business model.

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