Senior Regulatory Affairs Specialist, 2Care4Generics / 1857 / CLOSED

The Company
2care4 was founded in 2005. Since then, they have built solid experience in parallel import of pharmaceutical products within human medicine in the EU/EEA countries. The 2care4 Group has focused on the Nordic and German pharmaceutical markets within parallel imports and since 2015 with the establishment of 2care4 Generics also within development and marketing of generic pharmaceuticals.

The key to their success lies in their values, which they strive to live up to every single day. These values have helped them evolve from a small, local entrepreneurial company into a key supplier of pharmaceuticals to the Scandinavian markets.

2care4 Generics embraces creativity and always encourages their employees to contribute with ideas. They believe that their staff carry out their work in the best way when the right framework and the right opportunities for them to develop are in place. Their philosophy is that this is the way to achieve the greatest possible know-how.

The Group has grown to employ more than 300 people throughout Europe. As Europeans, they do their best to seek innovative solutions for continuous expansion through mutual respect and drive. You can work from Esbjerg, Odense or Home Based. Danish language is not mandatory. HQ is based in Esbjerg. See more at www.2care4.eu

Senior Regulatory Affairs Specialist

Engaged & Scientifically competent

You will be leading Regulatory Affairs development activities
Development and execution of regulatory and market access strategies for pipeline products
Evaluation and preparation of regulatory documentation and dossiers for pipeline products
Management of marketing authorization applications activities

The Challenge
You will work closely together with your team, the authorities, and internal and external partners. 2care4 Generics is in a very positive development and needs more resources for their newly established RA Development department currently consisting of 3 engaged Regulatory Affairs colleagues. Your role will be to secure marketing authorizations of new own-developed, co-developed and in-licensed products. You have the courage and experiences to bring your knowledge forth, support, coach and contribute as an RA expert and discuss strategies with your colleagues, external partners, and the Management Team.

Your team will be cooperating with many parts of the organization such as Business Development, Quality Assurance and Supply Chain, and will therefore not only be supporting Regulatory Affairs activities but will proactively be involved in optimizing the entire company value chain.

You will be working both as an expert with your own tasks and be involved in optimizing and prioritizing your team’s resources and projects. You are ambitious and go through different processes in order to drive the team most effectively for the benefit of the team and the company.

Your team works with management of pipeline products intended for the Nordic markets, and among others you will take care of tasks such as:

Participate in the strategic evaluation and preparation of pipeline products from the regulatory and market access perspective
Evaluation of regulatory documentation/dossiers for new products together with their external partners
Product information evaluation and preparation of SmPC, PIL and labeling
Communication with the regulatory authorities through the entire marketing authorization application (MAA) process
Preparation of MAA response- and updated dossier documentation in close collaboration with external partners
Monitor and implement current guidelines and regulatory requirements in the Nordic countries and the EMA region
Contribute to develop and build systems, procedures and SOPs that strengthen the products through the whole organization

2care4 Generics offers an exciting position within a dedicated company that is characterized by high quality, result orientation and speedy realization of the product in the value chain. You will be given the opportunity to put your mark on the job and lots of opportunities for personal and professional development. Since 2care4 Generics experiences rapid growth, there will be good career opportunities within the organization. You will be reporting to the Head of Regulatory Affairs & Pharmacovigilance.

Your Talent
You are passionate about RA strategies and have the ambition to create an environment where knowledge, education and development are part of the daily work life. You are a Pharmacist or have other relevant pharmaceutical background and a solid experience within Regulatory Affairs and project management from the generics pharmaceutical industry. You can work from Odense or be Home Based visiting when necessary.

You are ambitious and performance oriented. You are positive, committed, and full of drive. With the entire value chain in focus, you have the ability to organize and plan both your own and your team’s task. It is important that you are focused, can prioritize, and keep calm when deadlines are tight. You are good at solving problems and thrive with more tasks simultaneously. You are fluent in English, both written and spoken. In other words, you have a desire to support and enrich 2care4 Generics’ culture and would love to work in a leading company within generics.

Application
Best Talent is responsible for the recruitment process at 2care4 Generics and reviews your application on a confidential basis. Forward your application including your CV in English marked” 1857/ Senior Regulatory Affairs Specialist” by e-mail to job@besttalent.dk. Read more on www.besttalent.dk.