Director of Business Support & Medical Devices
Driven by research and a passion for science Ferring Pharmaceuticals is a biopharmaceutical company dedicated to the development of innovative treatments that make a real difference in people’s lives all over the world. Active in the areas of reproductive medicine & women’s health, urology and gastroenterology, we develop medicine on the body's own terms. We believe in the power of people and research - and go where ideas and research take us.
Would you like to join us in a challenging position as Director of Business Support & Medical Devices in Global Regulatory Affairs (GRA) reporting directly to the SVP of GRA?
Business Support & Medical Devices as part of Global Regulatory Affairs, consists of several regulatory sub-functions as well as a corporate Information Services & Archive function. The department comprises:
Medical Devices function (3 team members) responsible for registration and maintenance of Ferring’s medical devices, supporting development and lifecycle projects and activities. Head of MD teams reports directly to you.
Regulatory Support functions such as:
- Compliance (1 direct report), ensuring and monitoring that Global Regulatory Affairs and Central Archive comply with the Ferring’s Quality Management System as well as applicable GxP rules.
- Labelling (3 direct reports), facilitating the generation and maintenance process for product labelling, as well as the Labelling Committee and monitoring of labelling compliance. This is a newly established function, and you are expected to establish appropriate processes together with the team and relevant stakeholders.
- Certificates (1 direct report), supporting worldwide regulatory submissions with additional documentation such as GMP and ML certificates, CPPs, Certificates of Analysis, as well as signature and legalization thereof.
Corporate Information Services & Archive (7 team members) providing all Ferring employees worldwide with access to relevant information resources, information searching, scientific publication surveillance, and compliant central archiving of Ferring’s business critical documentation. Head of this department reports directly to you.
Physically, we are based at Ferring’s International PharmaScience Centre in Ørestad, Copenhagen.
We are looking for a Director to lead and grow the department. In this role, you will also be part of the Extended Leadership Team under the SVP of Global Regulatory Affairs.
Your main responsibilities will be:
- To manage and develop a high-performing department including employee development, performance setting and evaluation
- To manage departmental internal and external costs, as well as yearly budget setting
- To ensure the department is represented in the Management Review under the Medical Device Quality Management System
- To ensure support to and establishment of cross-functional processes
- To ensure compliance (Central Archive, MD and Labelling) with external regulations (GxP, GDPR, MDD and ISO standards) as well as internal procedures and quality standards
The ideal candidate:
- Has a master degree in pharmaceutical sciences or equivalent
- Has >5 years of proven leadership skills and in addition has significant experience (>10 years) from the pharma industry, preferably in global regulatory affairs
- Possesses excellent stakeholder management skills, has the ability to influence, is naturally outspoken and able to represent the department in any organizational setting
- Is fluent in English and has excellent IT skills
- Has strong leadership skills with a vision to further develop the department, and possesses strategic thinking
Moreover, you are a team player and enjoy working in a global setting with different cultures.
Expected start date 1 August 2018. For additional information, please contact Marianne Kock, SVP Global Regulatory Affairs on +45 28 78 75 52. Please send your application and CV as soon as possible and no later than 31 May 2018.