Senior Global Regulatory Affairs Manager, CMC, Ferring Pharmaceuticals /1692
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 they are nearly 600 people, primarily scientists and specialists working to break new land to help people live better lives. They focus their R&D efforts on peptide-based drugs and biotechnology derived medicines.
As a privately-owned company Ferring Pharmaceuticals 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 their 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 Ferring employees. Read more at ferring.com
To support the expanding portfolio and the continued global growth of Ferring Pharmaceuticals, they are now seeking a new employee to support the development of a new gene therapy product.
The Global Regulatory Affairs CMC department consists of 38 Regulatory Product/Project Managers and Regulatory Product Leads split in five teams with three teams based in Copenhagen, one team based in Israel and one team based in Switzerland. 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 is now expanding to also excel in other modalities as gene therapy.
You will be part of a dynamic team with engaged and dedicated people in a stimulating international environment, where you will have high influence on the working processes in this new area.
Senior Global Regulatory Affairs Manager, CMC
- Worldwide company with innovative treatments
- Making a real difference in people’s lives all over the world
- You have experience with gene therapy, leading and driving global RA activities
You can expect to be working towards achieving the highest standards of current practice in order to fulfill the company’s needs for CMC and product data acceptable worldwide.
You will be working with an innovative gene therapy project, which is new to the company and for which the regulatory strategy is currently being developed. We are looking for a strong candidate, who can actively drive and support the global project team in bringing this product to the market, including the following activities:
- Responsible for the global regulatory CMC strategy for the gene therapy development project with a focus on creativity and innovation, maximizing the business benefit balanced with regulatory compliance
- Lead global CMC submission activities for the assigned project, while applying the global strategy into submissions
- Build and provide regulatory CMC expertise within advanced therapy 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 the development project, ensure that adequate documentation is generated to support the change
- 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.
Ferring Pharmaceuticals is a growing organization offering you opportunities for personal development within an international environment. You will be encouraged and welcomed to bring forth new ideas, discuss concerns and share feed-back with colleagues and management. It is this freedom and respect shown to all employees, that makes Ferring Pharmaceuticals an attractive place to work. You will report to Associate Director, Global Regulatory Affairs, CMC, Urology.
The ideal candidate holds a degree in Life Science or Pharmacy, with at least 7 years of experience in Global Regulatory Affairs. Since gene therapy is a new modality in the portfolio, regulatory CMC experience with advanced therapy products is preferred. However, regulatory experience with biologics/biotech will also be considered.
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 motivated by having a high impact position and understand how to apply your cultural awareness to inspire trust and respect among your international colleagues. As a dedicated and flexible team-player, you utilise your high level of energy and can-do attitude to proactively handle the various tasks at hand.
Strong communication skills are essential in this role, which interacts with many other disciplines. You have the ability to work independently and as part of a project, and you are keen on working in a multi-cultural environment. You are of course proficient in English, both written and verbal.
Best Talent is responsible for the recruitment for this position at Ferring Pharmaceuticals and review your application on a confidential basis. Forward your application including your CV attention ”1992/RA CMC” by way of e-mail to email@example.com You can read more about Best Talent at www.besttalent.dk.