Senior Global Regulatory Affairs Manager, CMC
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 medicines & womens health, urology & uro-oncology and gastroenterology & liver diseases, 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.
To support our expanding portfolio and the continued growth of Ferring we are seeking a new colleague to the Global Regulatory Affairs CMC department at Ferring.
The Global Regulatory Affairs CMC department consists of 35 regulatory product/project managers and regulatory product leads split in four teams with three teams based in Copenhagen and one team based in Israel. The vacant position is in the Copenhagen team. The department is responsible for all global regulatory CMC activities during development, registration and approval as well as for worldwide market expansions and CMC lifecycle activities. The department has a robust expertise with small molecules, peptides, biologics and recombinant products and are now expanding to also excel in other modalities.
Reporting to Associate Director, Global Regulatory Affairs, CMC, your main responsibilities will be as listed below. You will be supporting or driving activities, depending on your level of experience:
- Formulate, lead and drive the global regulatory CMC strategy for development projects and marketed products with a focus on creativity and innovation, maximizing the business benefit balanced with regulatory compliance
- Lead global CMC submission activities for assigned projects/products, while applying the global strategy into submissions
- Responsible for regulatory submissions and approvals for worldwide market expansions and renewals
- Provide regulatory CMC expertise to cross-functional teams such as the Global Regulatory Project Teams, CMC Teams, Product Teams and Launch Teams
- Perform regulatory impact assessment of CMC changes for established products and development projects, ensure that adequate documentation is generated to support the change and ensure that the variation is approved by regulators
- Plan and participate in Health Authority meetings in relation to CMC activities. In close collaboration with subject matter experts you will be responsible for setting objectives, preparing briefing books, coordinating and planning rehearsals and risk mitigation plans in relation to meetings with Health Authorities
You will be working in an international environment and have interfaces with many different disciplines including other Regulatory disciplines, Global Pharmaceutical R&D, Product Supply, Ferring’s affiliates and development sites around the world.
The ideal candidate holds a degree in life science or Pharmacy, with at least 7 years of experience for a Senior position. Preferably the working experience includes regulatory CMC activities and preferably with a variety of modalities. You have excellent administrative skills and are good at communicating verbally and in writing.
You must have a proactive mindset and a desire to continuously develop and find innovative solutions to regulatory challenges. In addition, you are well-organized and have the ability to plan, execute and meet deadlines. You have good negotiation skills and can deal with ambiguity. You are a true team player, an experienced user of IT (including MS Office), and are keen on working in a multicultural corporate environment.
Further information about the positions can be obtained by contacting: Associate Director, Pernille Maria Manuel, Global Regulatory Affairs, CMC, Reproductive Medicine & Women’s Health. Mobile: +45 28787170
Your application and CV in English should be sent as soon as possible but no later than 23rd of April 2019, as we will be reviewing incoming applications on an on-going basis.