Head of Nordic Regulatory Affairs
Karo Healthcare, Norway
Job Description
Karo Healthcare offers a portfolio of everyday healthcare products and services that help prevent illness and treat health problems. With a wide range of trusted, documented, and original brands, backed by services for partners, customers, and consumers, we provide people with she options, knowledge, and access they need to stay healthy. We call it smart choices for everyday healthcare. We call it smart choices for everyday healthcare. We specialize in six product categories: intimate care, dermatology, footcare; pain, cough and cold; wellness; and Rx pharma care. Across these categories, we own a range of differentiated brands in both prescription drugs (Rx) and consumer products (OTC).
Karo Healthcare Group is a consumer healthcare company owning and commercializing approximately 110-120 brands in approximately 90 countries. Karo Healthcare Group is headquartered in Stockholm, Sweden, with offices also in the UK, Germany, Belgium, Denmark, Norway, Finland, Italy, Spain and the Netherlands. Karo Healthcare Group is on a growth journey where a combination of organic and Mamp;A driven growth is part of the strategy. Karo Healthcre Group is owned by EQT.
Roles amp; Responsibilities:
Our future Head of Nordic Regulatory Affairs (RA) will lead the Nordic RA team and play an important operational and strategic role for realizing Karo’s vision in becoming a global consumer health leader. Head of Nordic Regulatory Affairs will be operationally responsible for Karo’s Nordic medicinal portfolio and consumer healthcare portfolio consisting of cosmetics, medical devices, and foods. The portfolio is a mix of local products with full RA responsibility as well as products involving traditional affiliate duties.
Main responsibilities are:
- Leading the work and priorities of the Nordic RA team, having full line management responsibility
- Support the Nordic commercial teams in Sweden, Norway, Finland
- For the medicinal portfolio: Ensure adequate and timely planning, preparation, submission and follow up of regulatory procedures for the defined medicinal product portfolio and associated regulatory tasks.
- Manage the regulatory dossiers, life cycle management and compilation of submissions for medicinal products.
- For the consumer health portfolio: Manage and update the local brands’ technical documentation of medical devices in liaison with the global team, manage and update the PIF files of cosmetics and documents related to food products
Requirements
Qualifications and education:
- University degree in Life Science
- Good understanding of regulatory requirements and applicable legal frameworks
- Leadership experience
- Record of Variation management, strong working relationship/experience of local authorities Knowledge of relevant Norwegian and Nordic databases, such as Farmalogg, Felleskatalogen, vnr.fi, Fass etc.
- Artwork maintenance and associated label requirements
- Experience of mainly the national procedure, but also DCP and MRP
- Knowledge and experience in ISO13485, requirements of the medical device regulation, MDR, as well as EC 1223/2009 cosmetic regulation and related standards. Knowledge in regulations for food supplements and VLCD products is an advantage
- Record of cross-functional duties and interactions (within Scientific Affairs, towards Operations and commercial functions as well as external stakeholders and partners of different sorts)
- Languages: English and either Nordic language
Personal Profile:
- Ability to independently organising, sequencing, prioritising, and carrying out given tasks including decision making as necessary
- Open minded and appreciative towards an evolving and dynamic workplace where cross-functional collaboration and own initiatives are key.
- Care for the wellbeing of our colleagues and end-users of our products
Benefits
- Opportunity to create, grow, and encourage
- Apart from a competitive salary pack, there are lots of growth opportunities to meet your personal ambitions
- Flexible schedule and life work balance
- Responsibility for exciting and challenging projects that have a direct, visible impact on our customers and the industry
- Very positive work environment in a young, international, and motivated team
- Start-up spirit while being a part of the large international organization with strong values
Karo Healthcre has a Diverse amp; Inclusive environment. We are looking for qualified candidates irrespective of gender, gender identity, sexual orientation, ethnicity, race, religion, nationa