Global Regulatory Affairs Manager – CMC
4 months ago
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 project?
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.
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-established 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 position will be placed in Ferring’s spectacular brand-new facility located close to Copenhagen airport. Here you will be surrounded by highly skilled and 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 into 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 robust expertise with small molecules, peptides, biologics, recombinant products, and is expanding to also excel in other modalities including 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 and support each other across the organization to achieve excellence together. We are committed to support all employees in their career development and to ensuring all our team members receive the right level of support and progression.
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 on an ongoing basis and close the process when we find the right match.
If you have questions about the recruitment process, please contact Senior Talent Acquisition Sourcer, Patricia Martins. We are unable to offer relocation assistance for this position. Candidates must be located in the Øresund region or willing to relocate at their own expense.
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.
Location:
Ferring Denmark
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