Global Regulatory Affairs Manager – CMC

Job Description:

Would you like to join an international company with excellent development opportunities and an open work environment where your contributions will make a difference, as you take on CMC responsibility for one of our products and a development projects?

You will be part of our Small Molecule team, which is responsible for all global regulatory CMC activities during development, registration of worldwide market expansions and CMC lifecycle activities for small molecules and peptide products.

“You’ll work with incredible colleagues who are always ready to help. And if you have a great idea, we want to hear about it! As a company, we are very receptive to input and want you to contribute with your experience and expertise,” director Laura Duus Jespersen explains.

Ferring + you
Would you like to join us in a challenging position in our regulatory CMC department? We are looking for a new colleague to our team who will be responsible for one of our well-stablished products supporting the lifecycle projects.

We are looking for a Global Regulatory Affairs Manager who is interested in 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 positions will be placed in Ferring’s spectacular brand-new facility located close to Copenhagen airport. Here you will be surrounded by highly skilled and equally dedicated colleagues including various experts and specialists that you will collaborate with as part of your project execution.

Your day at Ferring

As a Global Regulatory Affairs Manager in our CMC department, you will, in collaboration with stakeholders (e.g. manufacturing sites, QA and supply organization), project team and colleagues within global regulatory affairs, be responsible for the lifecycle projects for one of our products. Reporting to the Director, your main responsibilities will be as listed below (depending on your level of experience):

• Responsible for the CMC part of regulatory submissions and approvals for worldwide market expansions and approvals 

• Provide regulatory CMC strategy and 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 the development projects and established product and drug substance, ensure that adequate documentation is generated, submitted and approved timely worldwide.

• Drive and execute Scientific Advice with national Competent Authorities in relation to CMC activities. 

• Participate actively in development and optimization of departmental and working processes.

Behind our innovation – There’s you

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, Quality Assurance, Ferring’s affiliates and development sites around the world.

To be successful in this role we believe that your CV comprises:  

• +5 years of experience in global regulatory affairs preferably within regulatory CMC activities.

• M.Sc. in a life science or pharmacy.

• Facilitation of risk management discussions is an asset.   

• A desire to find innovative solutions to regulatory challenges and a proactive mindset.

• Well-organized and can plan, execute and meet deadlines.

• True team player.

• Good negotiation skills and the ability to deal with ambiguity.

• Experienced use of IT (including MS Office),

People come first at Ferring
The Global Regulatory Affairs CMC department consists of approximately 30 global regulatory product/project managers, regulatory product leads, and medical device managers split in three teams all based in Copenhagen. You will be part of the Small Molecule team who are responsible for the small molecules and peptides products. 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, recombinant products and are expanding to also excel in other modalities incl. gene therapy.

Our philosophy of “people come first” is lived through every part of our business and applies both to our patients and employees worldwide. At Ferring we empower