Regulatory Affairs Manager

Job Title: Regulatory Affairs Manager

Job Type: Permanent, full-time

Location: Norway, Remote (however, MUST be living in Norway and hold the full right to work)

An opportunity working for a leading CRO that collaborates with a number of large pharmaceutical and growing biotech’s. An opportunity as a Regulatory Affairs Manager has become available to join the 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. The Regulatory Affairs Manager should be able to handle medical translations, particularly product information texts, from English into Norwegian, as well as other medical and scientific content. 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 the Line Manager.

·      Participation in regulatory processes to gain and maintain marketing authorisations 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.

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 a plus.

·      Strong teamwork skills.

·      A flexible and proactive attitude.

·      Project management skills and ability to handle tight schedules.

For more information, please reach out to me at [email protected]