Global Regulatory Affairs Manager
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 health, urology, gastroenterology, endocrinology and orthopedics, 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 Global Regulatory Affairs Manager in Global Regulatory Affairs?
We have an open position within Global Regulatory Affairs; where you will be playing a key role in the Lifecycle Management of our reproductive health & obstetrics products.
Your primary tasks will consist of the following:
- Regulatory submissions for approval of new products and line extensions to the existing portfolio: managing the preparation, content and format of the dossier, responding to authority questions
- Driving submissions of variations, renewals and supplements for assigned products
- Liaison with Health Authorities, including planning and execution of scientific advice meetings
- Contribution to multi-disciplinary project teams incl. clinical trials
- Preparation and maintenance of prescribing information (CCDS, SPCs, Package inserts, labels)
- Interaction with stakeholders, including manufacturing sites, marketing and local regulatory affairs managers.
- Preparation and presentation of regulatory product strategies
- Evaluation and communication of regulatory requirements for approval
- Document handling and interactions with data entry team in Document management systems and regulatory status databases
The ideal candidate holds a degree in pharmacy or life sciences, preferably with 3 years of experience in International Regulatory Affairs. Excellent administrative skills, as well as good verbal/written communication skills in English are essential. The candidate must have an innovative mind-set, be flexible, self-starting and be a problem solver with the ability to work on multiple tasks in a thorough and systematic way.
We pride ourselves in working as a team, so you should be an effective team player. Finally the candidate is an experienced user of IT (including MS Office) and is keen on working in a multicultural corporate environment.
Further information about the positions can be obtained by contacting Rasmus Callesen, Associate Director on tel. +45 28 78 76 67. Your application and CV in English should be sent as soon as possible and no later than 30 September 2016.