( Senior ) Global Regulatory Affairs Managers, CMC, Ferring / 1648
Driven by research and a passion for Science, Ferring Pharmaceuticals is a Biopharmaceutical company dedicated to the development of innovative treatments which make a real difference in people’s lives all over the world. Active in the areas of Reproductive Health, Urology, Gastroenterology, Endocrinology and Orthopedics’. Ferring Pharmaceuticals develop medicine on the body's own terms. Ferring Pharmaceuticals believe in the power of people and research - and go where ideas and research take them. To sustain the effort of developing new medicine, Ferring Pharmaceuticals reward talent with influence. In return, employees are expected to be ambitious and innovative. See more at www.ferring.com
To support the expanding portfolio and the continued global growth of Ferring they are seeking new employees with various degrees of seniority to the Global Regulatory Affairs CMC department at Ferring.
The Global Regulatory Affairs CMC department consists of 30 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 positions are all in the Copenhagen teams. 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.
You will be part of a dynamic team with approx. 30 engaged and dedicated people in a stimulating international environment, where you will have high influence on the working processes.
(Senior) Global Regulatory Affairs Managers, CMC
Cooperation and Can-Do Attitude
• Worldwide company with innovative treatments
• Making a real difference in people’s lives all over the world
• You have experience with formulating, leading and driving global RA CMC 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 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.
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 all 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
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 an Associate Director, Global Regulatory Affairs, CMC either within Reproductive Medicine & Women’s Health or Urology & Uro-oncology.
The ideal candidate holds a degree in Life Science or Pharmacy, with at least 3 years of experience in Global Regulatory Affairs for a Global Regulatory Affairs Manager position and 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 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. As a person you are self-driven and dependable with a good sense of humor. 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 ”1648/RA CMC” by way of e-mail to firstname.lastname@example.org You can read more about Best Talent at www.besttalent.dk.