Regulatory Affairs Manager

PharmaLex, a Cencora company, is one of the leading service providers for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, of the market development and any action of effective product maintenance. The success of our company resides in the expert knowledge and high motivation of our employees. Working for Pharmalex means being creative and adaptive. Our culture of continuous learning and commitment to diversity and inclusion creates an environment that allows you to build your skills and career.

We have an opportunity for an experienced Regulatory Affairs Manager to join our Nordic Regulatory team in Norway. In this role you will have the opportunity to work with a broad range of pharmaceutical clients. You will advise, support and manage regulatory submissions and approvals for medicinal products, including liaising with clients and working collaboratively with global, regional and local colleagues. Additionally, this role includes translations and reviews of product information texts and a wide variety of other text types for the pharma industry. 

Responsibilities

• Develop and maintain strong client relationships and actively explore opportunities for increased service support to Line Manager.

• Participation in regulatory processes to gain and maintain marketing authorizations for human and veterinary medicinal products (applications, renewals, variations) including medical devices, cosmetics, food supplements and herbal products.

• Preparation, review and compilation of documents within the framework of

• regulatory affairs projects.

• Translation and review of product information texts and other types of texts for the pharma industry.

• Communication with clients and Health Authorities.

• Support with scientific advice procedures and representation of clients with health authorities.

• Responsible for the planning and execution of client projects in accordance with KPIs

• Coordination of project teams with colleagues and qualified external

• partners.

• General guidance (consultancy) of colleagues and clients regarding Regulatory

• Strategy and Procedure Management.

• Regulatory intelligence - develop and maintain personal regulatory knowledge,

• apply to client projects and actively share with colleagues.

• Present seminars and lectures for colleagues, clients and professional audiences.

• Active contribution and distribution of department relevant expertise.

• Support with strategy implementation and optimization.

• Comply with, maintain and contribute to optimizing internal processes.

• Support with ed commercial, marketing and business development activities including proposal input

• Support respective lead in delivery to budget with accurate and timely reporting and provide project insights to address invoicing queries.

• Providing on-site regulatory support to clients.

Education

• University degree in Life Science.

Experience

• Several years’ experience and profound knowledge in the field of regulatory affairs.

• Expertise, experience and knowledge on relevant EU and local legislative and guidelines on regulatory affairs.

Skills

• Native speaker of Norwegian and strong English. Other language skills, particularly in other Nordic languages, are plus.

• Strong teamwork skills.

• A flexible and proactive attitude.

• Project management skills and ability to handle tight schedules.