Global Regulatory Affairs Manager – CMC

2 months ago


København, Denmark Ferring Pharmaceuticals AS Full time

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

#J-18808-Ljbffr

  • København, Denmark Genmab AS Full time

    The Genmab Vacancy Website is hosted by our Global HR System vendor, Workday. If you have any questions related to the hosting of this site please contact us at Director/Associate Director, Global Regulatory Affairs - CMC At Genmab, we’re committed to building extraordinary futures together, by developing antibody products and pioneering therapies that...


  • København, Denmark Genmab Full time

    At Genmab, we’re committed to building extraordinary futures together, by developing antibody products and pioneering therapies that change the lives of patients and the future of cancer treatment and serious diseases. Our people are caring, candid, and impact-driven, and our business is innovative and rooted in science. We believe that being proudly...

  • Global Regulatory Lead

    2 months ago


    København, Denmark Ferring Pharmaceuticals AS Full time

    Are you an experienced Regulatory Affairs Professional, and do you want to help drive the development of the current and next generations of Ferring’s health care solutions that help people live better lives? Then come join us in a challenging position in one of our Global Regulatory Affairs Therapeutic Area teams. Ferring is dedicated to advancing...


  • København, Denmark Genmab Full time

    At Genmab, we’re committed to building extra(not)ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in...


  • København, Denmark Genmab AS Full time

    Senior Director, Regulatory Affairs Strategy-EU/RoW At Genmab, we’re committed to building extraordinary futures together, by developing antibody products and pioneering therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is...


  • København, Denmark Genmab Full time

    At Genmab, we’re committed to building extraordinary futures together, by developing antibody products and pioneering therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science, we believe that being...


  • København, Denmark Genmab Full time

    At Genmab, we’re committed to building extraordinary futures together, by developing antibody products and pioneering therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science, we believe that being...


  • København, Denmark Genmab Full time

    At Genmab, we’re committed to building extraordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science,...


  • København, Denmark Genmab AS Full time

    The Genmab Vacancy Website is hosted by our Global HR System vendor, Workday. If you have any questions related to the hosting of this site please contact us at (Senior) CMC Technical Integration Manager Locations: Copenhagen Time Type: Full time Posted on: Posted 2 Days Ago Job Requisition ID: R11639 At Genmab, we’re committed to building extraordinary...


  • København, Denmark Genmab AS Full time

    The Genmab Vacancy Website is hosted by our Global HR System vendor, Workday. If you have any questions related to the hosting of this site please contact us at . Associate Director, EU/ROW Regulatory Lead page is loaded Associate Director, EU/ROW Regulatory Lead Apply locations Copenhagen time type Full time posted on ...


  • København, Denmark Global Fashion Agenda Full time

    Global Fashion Agenda is looking for an outgoing and structured intern to support its Public Affairs team. The paid internship begins in January 2025 and lasts for six months (exact dates are flexible to accommodate the feasibility of higher education institutions). The internship will take place at the GFA office in Copenhagen, or remotely. As an...


  • København, Denmark Just-Eat.dk ApS Full time

    Public Affairs and Corporate Communications Manager Placering CopenhagenWe are embarking on a new chapter where we lead by setting entirely new standards for the industry. We are in a growing market with many exciting new opportunities! Do you want to join us on this journey and help us establish new milestones for the future of Just Eat? Then continue to...


  • København, Denmark Genmab Full time

    At Genmab, we’re committed to building extraordinary futures together, by developing antibody products and pioneering therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science, we believe that being...


  • København, Denmark Voisin Consulting SARL Full time

    Senior Regulatory Scientist We are continuing to invest in growing our Nordic business and are now seeking to hire Senior Regulatory Scientists. This role will speak to those who are excited at the pace of change and innovation in Life Science, who want have an appetite to partner the most cutting edge clients and those who want to continuously learn,...

  • Senior QC Scientist

    2 months ago


    København, Denmark H. Lundbeck AS Full time

    Senior Quality Control Scientist, QC CMC Biologics Do you want to join our international CMC Biologics Quality Control team? And are you eager to work in an international setting where empowerment and cross functional collaboration skills are key? Then you might be our new Senior Quality Control Scientist! Your new role – why is this a great opportunity? ...


  • København, Denmark Radiometer Danmark Danaher Full time

    In our line of work, life isn’t a given - it’s the ultimate goal. When life takes an unexpected turn, our technology and solutions enable caregivers to make informed diagnostic decisions to improve patient care. This is our shared purpose at Radiometer and what unites all +4000 of us - no matter our roles or where in the world we’re located. Creating...


  • København, Denmark ABACUS MEDICINE AS Full time

    Drive meaningful change in Regulatory Marketing Authorization In Regulatory, we obtain licenses for parallel trading of medicine. We do this by submitting applications to the European Medicines Agency and national medicine agencies of our sales countries. Our department is responsible for making sure that Abacus Medicine can parallel trade medicines as...


  • København, Denmark Genmab Full time

    At Genmab, we’re committed to building extraordinary futures together, by developing antibody products and pioneering therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science, we believe that being...


  • København, Denmark Genmab Full time

    At Genmab, we’re committed to building extraordinary futures together, by developing antibody products and pioneering therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science, we believe that being...

  • Regulatory Manager

    2 months ago


    København, Denmark Nordea Full time

    København S, DK, 2300 Job ID: 23315 Are you passionate about navigating regulatory changes and staying ahead of the regulatory trends? We are seeking a dynamic Regulatory Manager to join our team and support our organization in analyzing the impact of upcoming EU and local Nordic regulatory changes. At Nordea, we’re committed to being a partner our...