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Global Regulatory Affairs Manager, CMC

Ferring Pharmaceuticals A/S

Virksom - a-kasse og faglig organisation for selvstændige


Global Regulatory Affairs Manager
Would you like to join us in a challenging position as a Global Regulatory Affairs Manager (GRAM) for Gastro & Urology products in our regulatory CMC department? We offer an exciting job in an international company with great development possibilities, an entrepreneurial and open work environment, where your contributions will be valuable and make a difference.

The job

Reporting to Associate Director, Global Regulatory Affairs, CMC, Gastro & Urology, your main responsibilities will be as listed below:

  • 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, submitted and approved timely worldwide
  • Participate actively in development and optimization of departmental and working processes
  • Support GRA CMC activities for Health Authority meetings and global strategies, working closely with the Senior GRAM or the Associate Director.

You will be supporting or driving activities, depending on your level of experience.

In the role you will work in an international environment and have interfaces with many different disciplines including other Global Regulatory disciplines, Global Pharmaceutical R&D, Manufacturing sites, Product Supply, Ferring’s affiliates and development sites around the world.

Qualifications

The ideal candidate holds a degree in life science or pharmacy, with at least 3 years of experience in global regulatory affairs, preferably within regulatory CMC activities.

You must have a proactive mindset and a desire to continuously develop and find innovative solutions to regulatory challenges, which you are able to communicate well verbally and in writing. In addition, you are well-organized and can 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.

Your new department

The Global Regulatory Affairs CMC department consists of 37 global regulatory product/project managers, regulatory product leads and medical device managers split in five teams with three teams based in Copenhagen, one team based in Israel and one team based in Switzerland. You will be part of the Gastro & Urology team based in Copenhagen. 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 for products and medical devices. The CMC department has a robust expertise with small molecules, peptides, biologics and recombinant products.

Contact and application

If you have any questions, you are very welcome to contact Associate Director, Laura Duus Jespersen, Global Regulatory Affairs, CMC, Gastro & Urology. Mobile: +45 28787644.

Your application and CV in English should be sent as soon as possible but no later than 11 October 2020, as we will be reviewing incoming applications on an on-going basis.

Ferring Pharmaceuticals is a leader in reproductive medicine and maternal 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 maternal 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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Ansøgningsfrist d. 11.10.2020
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Storkøbenhavn
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Kemi, Biotek & Materialer
Medicinal & Sundhed
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Medicinal & Sundhed
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Ferring Pharmaceuticals A/S - hurtigt overblik


Ferring Pharmaceuticals A/S
Ferring Pharmaceuticals A/S
Ferring is a research-driven, specialty biopharmaceutical group committed to helping people build healthy families and live better lives. Ferring is a leader in reproductive medicine and maternal health, and in specialty areas within gastroenterology and urology.

Placering
Kay Fiskers Plads 11
2300 København S
Logo: Ferring Pharmaceuticals A/S
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