Job Title:

Global Regulatory Affairs Project Lead

Job Description:

Global Regulatory Project Lead – Microbiome Therapies

Global Regulatory Affairs, Clinical and Non-Clinical

Would you like to join us in a challenging position as Global Regulatory Project Lead for our next generation microbiome therapies in the Global Regulatory Affairs, Clinical and Non-Clinical area at Ferring? We offer an exciting job in an international company with great opportunities to collaborate with colleagues across the world and to make an impact for the many people in need of new innovative microbiome therapies.

The job

Your main responsibilities will be as follows:

• Member of Global Project Team and chair of the Global Regulatory Project Team for a microbiome capsule in late stage development for treatment of recurrent CDif infection.
• Ensuring collaboration with the global regulatory team in preparing global regulatory strategies, identifying regulatory opportunities and mitigating risks, developing competitive labels, preparing road-maps for global regulatory submissions and coordinating regulatory activities in collaboration with relevant team members.
• Planning and managing meetings with Health Authorities worldwide. You will be driving and leading the preparation of high-quality briefing packages and liaise with the Health Authorities and experts to obtain important scientific advices.
• Ensuring compilation, submission and approvals of CTAs and INDs for all clinical trial related regulatory activities as well as maintaining these throughout the product development phases.
• Ensuring compilation, submission and approvals of NDAs and MAAs in the Europe, US, Japan, China and other countries worldwide in collaboration with local regulatory colleagues.
• Supporting regulatory Labelling, Non-Clinical & Clinical documentation for all market expansions, including responses to authority questions.
• Performing review of clinical trial and safety documentation e.g. IB, DSUR, clinical trial protocol and report, DSUR, RMP and represent regulatory in clinical trial and safety team meetings.

Qualifications

The ideal candidate holds a degree in Life Science or Pharmacy, with more than 8 years’ experience with managing global regulatory activities and preferably with experience from working with labelling, clinical trials and other clinical and non-clinical regulatory activities.

You must have a proactive, strategic mind-set combined with the ability to plan and execute regulatory submissions. You have good negotiation skills as well as good judgment and decision-making skills. You are a true team player with a positive mind-set and a constructive attitude to drive results, and you are keen on working in an international corporate environment.

Excellent verbal and written communication skills in English are important.

Your new team

You will join the Global Regulatory Affairs, Clinical and Non-Clinical department which supports all global projects as well as life cycle management of marketed products, including market expansions, product extensions or updates worldwide from a regulatory Clinical, Non-Clinical and Labelling perspective. The area is also providing oversight of new regulatory intelligence developments and input to evaluation of external innovation.

Your new workplace is first at the Ferring International Pharma-Science Center (IPC) in Ørestad, Copenhagen. However, later in 2021 we will move to our spectacular and state-of-the-art new domicile, a future landmark located next to “Den Blå Planet”, near Copenhagen Airport.

Contact and application

Please send your application and CV no later than 10 May 2021. If you have any questions, you are welcome to contact Lene Melchiorsen, Vice President at +45 2878 7680.

Please note that we review applications on an on-going basis and close the process when we find the right match.

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