Global Regulatory Affairs Manager – CMC

3 months ago

Kastrup, Denmark Ferring Pharmaceuticals Full time

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.

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 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 on-going basis 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 Øresund region or willing to relocate at their own expense.

Location:

Ferring Denmark

  • Global Regulatory Affairs Manager – CMC

    2 weeks ago

    Kastrup, Denmark Ferring Pharmaceuticals, Inc. Full time

    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 project? You will be part of our Small Molecule team, which is responsible for all global...

  • Global Regulatory Affairs Manager

    5 days ago

    Kastrup, Denmark Ferring Pharmaceuticals Full time

    About the RoleWe are seeking a highly skilled Global Regulatory Affairs Manager to join our CMC department at Ferring Pharmaceuticals. As a key member of our team, you will be responsible for ensuring the regulatory compliance of our products and ensuring that our development projects meet the highest standards of quality and safety.Key...

  • Global Regulatory Affairs Manager

    1 week ago

    Kastrup, Denmark Ferring Pharmaceuticals Full time

    About the RoleWe are seeking a highly skilled Global Regulatory Affairs Manager to join our team at Ferring Pharmaceuticals. As a key member of our Small Molecule team, you will be responsible for ensuring the regulatory compliance of our products and development projects.Key ResponsibilitiesDevelop and implement regulatory strategies for CMC activities,...

  • International CMC Regulatory Affairs Leader

    1 week ago

    Kastrup, Denmark Ferring Pharmaceuticals Full time

    Position Overview:Are you ready to be part of a global organization that values your input and fosters a collaborative atmosphere? In this role, you will take charge of CMC responsibilities for one of our key products and development initiatives.Join our Small Molecule team, dedicated to overseeing all global regulatory CMC activities throughout the...

  • International CMC Regulatory Affairs Lead

    1 week ago

    Kastrup, Denmark Ferring Pharmaceuticals Full time

    Position Overview:Are you interested in becoming part of a global organization that values your contributions and offers exceptional career growth in a collaborative environment? In this role, you will take on CMC responsibilities for one of our established products and contribute to various development initiatives.As a member of our Small Molecule team, you...

  • Regulatory Affairs Specialist

    1 week ago

    Kastrup, Denmark Ferring Pharmaceuticals Full time

    About the RoleWe are seeking a highly skilled Global Regulatory Affairs Manager to join our team at Ferring Pharmaceuticals. As a key member of our Small Molecule team, you will be responsible for ensuring the regulatory compliance of our products and development projects.Key ResponsibilitiesDevelop and implement regulatory strategies for CMC activities,...

  • Regulatory Affairs Professional

    1 week ago

    Kastrup, Denmark Ferring Pharmaceuticals Full time

    About the RoleWe are seeking a highly experienced Regulatory Affairs Professional to join our Global Regulatory Affairs Therapeutic Area team at Ferring Pharmaceuticals. As a key member of our team, you will be responsible for driving the development of high-quality global regulatory strategies and ensuring compliance with regulatory requirements.Key...

  • Regulatory Affairs Professional

    1 week ago

    Kastrup, Denmark Ferring Pharmaceuticals Full time

    About the RoleWe are seeking a highly experienced Regulatory Affairs Professional to join our Global Regulatory Affairs Therapeutic Area team at Ferring Pharmaceuticals. As a key member of our team, you will be responsible for driving the development of high-quality global regulatory strategies and ensuring compliance with regulatory requirements.Key...

  • Global Regulatory Lead

    2 weeks ago

    Kastrup, Denmark Ferring Pharmaceuticals, Inc. Full time

    Job Description: 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...

  • Global Regulatory Strategy Manager

    1 week ago

    Kastrup, Denmark Ferring Pharmaceuticals Full time

    About the RoleWe are seeking a highly experienced Regulatory Affairs Professional to join our Global Regulatory Affairs Therapeutic Area team at Ferring Pharmaceuticals. As a key member of our team, you will be responsible for driving the development of high-quality global regulatory strategies and ensuring compliance with regulatory requirements.Key...

  • Global Regulatory Lead

    1 month ago

    Kastrup, Denmark Ferring Pharmaceuticals AS Full time

    Job Description: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...

  • Global Regulatory Lead

    1 month ago

    Kastrup, Denmark Ferring Pharmaceuticals Full time

    Job Description: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...

  • Global Regulatory Lead

    1 week ago

    Kastrup, Denmark Ferring Pharmaceuticals Full time

    About the RoleWe are seeking a highly experienced Regulatory Affairs Professional to join our Global Regulatory Affairs Therapeutic Area team at Ferring Pharmaceuticals. As a key member of our team, you will be responsible for driving the development of high-quality global regulatory strategies and ensuring compliance with regulatory requirements.Key...

  • Global Regulatory Lead

    1 week ago

    Kastrup, Denmark Ferring Pharmaceuticals, Inc. Full time

    About the RoleWe are seeking a highly experienced Global Regulatory Lead to join our Therapeutic Area team at Ferring Pharmaceuticals, Inc. This is a challenging position that requires a strong regulatory background and expertise in driving the development of global health care solutions.Key ResponsibilitiesRepresent the Global Regulatory Affairs function in...

  • Market Supply Chain Lead

    3 weeks ago

    Kastrup, Denmark Ferring Pharmaceuticals AS Full time

    Job Description: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...

  • Global Technical Customer Support Manager

    3 days ago

    Kastrup, Denmark Kassow Robots ApS Full time

    Copenhagen, DNFull-timeEngineerKassow Robots is a dynamic player in the robotics industry, building and developing a unique range of collaborative robot arms. We are searching for a highly skilled Quality Engineer with a proven track record in Quality Management, Quality Control, and Assurance.Kassow Robots has recently joined forces with Bosch Rexroth, a...

  • Market Supply Chain Lead

    2 weeks ago

    Kastrup, Denmark Ferring Pharmaceuticals Full time

    Job Description: 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...

  • Market Supply Chain Lead

    3 weeks ago

    Kastrup, Denmark Ferring Pharmaceuticals Full time

    Job Description: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...

  • Nordic MSL/Medical Advisor, Respiratory, Chiesi Nordic

    2 weeks ago

    Kastrup, Denmark Dedicare Full time

    Do you want to work as Medical Advisor/MSL in a Nordic company with an entrepreneurial and value-driven culture? We are now searching for a professional and engaged Medical Advisor/MSL to support the Nordic team at Chiesi. Responsibilities Provide fair and balanced field-based medical and scientific support in response to specific requests from healthcare...

  • Clinical Program Lead

    2 weeks ago

    Kastrup, Denmark Ferring Pharmaceuticals AS Full time

    Job Description:Clinical Program Lead – use your stakeholder management skills  Can you navigate complex stakeholder landscapes and drive clinical development programs?Do you thrive in a core role that requires a strategic overview, a continuous flow of information, and the ability to ‘connect the dots’ to ensure progress? As part of Ferring’s...