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Hjem - Associate Director, Global Regulatory Affairs, CMC

Associate Director, Global Regulatory Affairs, CMC

Associate Director, Global Regulatory Affairs, CMC
Udefinereret

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 & women’s 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.

We are currently looking for an Associate Director as a new team lead and colleague in the Global Regulatory Affairs CMC department at Ferring.

THE DEPARTMENT
The Global Regulatory Affairs CMC department consists of 35 global regulatory product/project managers, CMC writers and regulatory product leads split in five teams, with three teams based in Copenhagen, one team in Israel and one team in Switzerland. The vacant position is in the Copenhagen team heading up the Urology and Uro-oncology team consisting of 7 team members.

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. Recently the department has been expanded to include a RA CMC writing team based in Switzerland.  

As a management team, we are committed to nurturing an ambitious and stimulating culture. Our vision is for the department to be continuously acknowledged and recognised for regulatory excellence providing high-quality strategies and innovative solutions to regulatory challenges.

THE JOB
Reporting to the Vice President, Global Regulatory Affairs CMC, you will be part of the GRA CMC Management group and leading the Urologv and Uro-oncology team. Your main responsibilities as will be:

  • As part of the management team, you will be responsible for setting direction, supervising and developing employees and the department and ensuring high standards, science and regulatory compliance
  • As Head of the team, you will be accountable for global regulatory CMC activities during development, registration, worldwide market expansions and CMC lifecycle activities for Ferring’s urology and uro-oncology products
  • Setting objectives and goal for the team members, performance review, as well as budget setting
  • Lead and contribute to RA and cross-functional process optimization, and represent GRA CMC in cross-functional committees, projects and initiatives
  • Provide guidance and regulatory CMC expertise to the team as well as to cross-functional teams such as the Global Regulatory Project Teams, CMC Teams, Product Teams and Launch Teams, as needed
  • Guide the team and ensure it drives the global regulatory CMC strategy for development projects and marketed products ensuring business benefit balanced with regulatory compliance. For certain projects, you may be responsible for driving the regulatory strategy
  • Ensure that the team performs regulatory impact assessment of CMC changes for established products and development projects, ensure that adequate documentation is generated, submitted and approved timely worldwide
  • Ensure leadership of global CMC submission activities for the projects/products, while applying the global strategy into submissions – either by yourself of through the team members
  • Support/drive Health Authority meetings, as needed, in relation to CMC activities. In close collaboration with the team and the subject matter experts you will be responsible for setting objectives, preparing/reviewing briefing books, coordinating and planning rehearsals and risk mitigation plans in relation to meetings with Health Authorities
  • Ensure regulatory CMC input as part of due diligence process

You will be working in an international, dynamic environment and have interfaces with many different disciplines including other Global Regulatory disciplines, Global Pharmaceutical R&D, Global Technical Operations, Global Quality Assurance, Ferring’s affiliates and manufacturing sites around the world.

YOUR QUALIFICATIONS

The ideal candidate holds a degree in life science or Pharmacy, with at least 10 years of international regulatory experience and preferably leadership experience, form either direct reporting or project management. Your working experience includes regulatory CMC activities and preferably with a variety of modalities.

You are visionary, decisive, have excellent people management skills and can set direction. You are a strong communicator and have the ability to plan, execute and meet deadlines. You must have a proactive mindset, embrace ambiguity and have a desire to continuously develop and find innovative solutions to challenges.

ADDITIONAL INFORMATION
Further information about the positions can be obtained by contacting Tamara Vukmirovic, VP Global Regulatory Affairs, CMC. Mobile: +45 28787817

Your application and CV in English should be sent as soon as possible but no later than 27 September 2019, as we will be reviewing incoming applications on an on-going basis.

Ferring Pharmaceuticals is a leader in reproductive medicine and women’s health, and in specialty areas within gastroenterology and urology. At Ferring International PharmaScience Center (IPC) in Copenhagen we are nearly 600 people, primarily scientists and specialists working to break new land to help people live better lives. We focus our R&D efforts on peptide-based drugs and biotechnology derived medicines. 

As a privately-owned company we benefit from the privilege to think and work with a long-term horizon. You will experience the same freedom in your search for new solutions. Your desire to innovate and explore will contribute to fulfilling our ambition of becoming the world’s leading company within reproductive medicine and women’s health. If you need help, you will find it. If you want challenges, they are right in front of you. If you are looking for freedom to find your own way, you are trusted to do so. If you want to make a mark in the world for the better, you feel just like the rest of us. Read more at ferring.com

Location:
Ferring Denmark

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