Global Regulatory Affairs Manager, 1-year contract

Job Description:

Do you want to spend your workdays in a multicultural corporate environment where you can continuously develop your skills and help find innovative solutions to regulatory challenges?

We are currently looking for a skilled regulatory affairs manager to join our department at the Ferring International PharmaScience Center (IPC) in Kastrup, Copenhagen for a 12-month period. Here, you’ll become part of the Global Regulatory Affairs function, working on lifecycle management activities and projects within our Urology portfolio.

Ferring + you

The Global Regulatory Affairs Urology team consists of nine dedicated employees and four students, and together we are responsible for all regulatory activities during development, registration, and approval, as well as lifecycle activities for products within our Urology portfolio.

In our team, we are keen to see our colleagues succeed. We offer support and help where we can, and value the social aspects of going to work - all while maintaining high professionalism.

Your day at Ferring
In the role of Global Regulatory Affairs Manager, you will be responsible for CMC activities related to the life cycle management of our Urology products.  

Depending on your experience, you will drive or support the following activities:

• be responsible for the CMC aspect of regulatory submissions and approvals for worldwide market expansions and renewals
• provide regulatory CMC strategies and expertise to cross-functional teams such as global regulatory project teams, CMC teams, product teams, and launch teams
• represent Global Regulatory Affairs (GRA) in due diligence processes and provide GRA CMC input
• perform regulatory impact assessments of CMC changes for established products and drug substances – and ensure that adequate documentation is generated, submitted, and approved on time worldwide

Behind our innovation – there’s you

As a valued stakeholder in the organization, you are well-organized, which means you can plan, execute, and meet deadlines, allowing you to act as a representative for GRA CMC in cross-functional project teams.

We imagine that you:

• have a degree in life science or pharmacy
• have solid experience in global regulatory affairs (preferably CMC)
• have experience with CMC documentation and global variation packages
• have excellent communication skills – verbal and written  
• are a true team player who is excited to make a positive impact on your surroundings

People come first at Ferring
Our philosophy of “People come first at Ferring” is lived through every part of our business. ​Our mission is to develop treatments to care for others, while we also care for each other.

We want you to enjoy all that life has to offer, along with purpose-driven work. We have an inclusive and flexible environment where employees can work remotely 1 day per week and on-site the remaining four.
 

Behind our purpose – there’s you
If our mission and your vision are aligned, please apply. Kindly include a few lines regarding your motivation for applying in the CV or a cover letter. Please note that we review applications continuously and close the process when we find the right match.

We are unable to offer relocation assistance for this position. Candidates must be located in the Oresund region or willing to relocate at their own expense.
 

Note to agencies: This search is being managed by Ferring’s Talent Acquisition team. Kindly do not send us unsolicited profiles.

 At Ferring Pharmaceuticals, we help people around the world build families and live better lives. We are entrepreneurial and innovative, with a global team focused on scientific advances in the areas of reproductive and women’s health, gastroenterology and urology. Ferring + You is all about working together and sharing ideas, so that we can bring science to life for patients around the world. Read more at ferring.com.

Location:

Ferring Denmark