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Ferring Pharmaceuticals

Global Regulatory Affairs CMC Lead

Fuldtid

Permanent

København, Tårnby

SE PÅ KORT
ID: 2533351
|
Indrykket for 55 dage siden

Job Description:

Global Regulatory Affairs CMC Lead

Use your experience with advanced therapy medicinal products in Global Regulatory Affairs – CMC

Do you want to use your experience with development and advanced therapy medicinal products to tackle CMC challenges and influence strategic decision-making as we roll out a new product worldwide?

Our team is expanding to support ongoing development activities, market expansions, and lifecycle projects for our newly approved gene therapy product.

director Mette Sonne explains.


Ferring + you
You can look forward to joining our Global Regulatory Affairs CMC Biologics team, where you can share strategies and ideas with your fellow CMC colleagues.

Within the broader Global Regulatory Affairs CMC department, we represent expertise in small molecules, peptides, biologics, recombinant products, and medical devices, and we are expanding to also excel in other modalities, including gene therapy.
 

Your day at Ferring
Most of your time will be spent contributing to a cross-functional team, representing regulatory CMC, and working alongside highly skilled and equally dedicated colleagues across our organization.

You will collaborate with specialists from various disciplines, including colleagues from our sister teams in Global Regulatory Affairs as well as Global Pharmaceutical R&D, manufacturing sites, Product Supply, affiliates, and development sites worldwide.

Drawing on your experience with advanced therapy medicinal products, you will:

  • act as a regulatory CMC representative and responsible for the regulatory CMC aspects of regulatory submissions and approvals for worldwide market expansions and approvals
  • provide regulatory CMC strategy and expertise to cross-functional teams such as our global regulatory project teams, CMC teams, product teams, and launch teams
  • represent Global Regulatory Affairs in the due diligence process and provide GRA CMC input
  • perform regulatory impact assessments of CMC changes for development projects and established products and drug substances, and ensure that adequate documentation is timely generated, submitted, and approved worldwide
  • drive and execute authority interactions with national Competent Authorities concerning CMC activities
  • participate actively in the development and optimization of departmental and working processes
  • Your primary work location will be our state-of-the-art new International PharmaScience Center in Copenhagen, where we offer spectacular views and a range of social activities. You will also get the option of working from home up to 2 days a week, allowing you to structure your workday to suit your professional and personal needs.
     

    Behind our innovation – there’s you
    You bring a proactive mindset and a desire to find innovative solutions to regulatory challenges, which could be tied to, e.g., the submission of the first MA or interacting with health authorities.

    To be able to do so, we imagine that you have extensive experience with global regulatory affairs CMC development projects. More specifically, we are looking for:

  • 8+ years of relevant experience – at least 3 of which have been with advanced therapy products
  • an M.Sc. in life science or pharmacy
  • several years of experience with biologics/biotech
  • experience with the facilitation of risk management discussions
     
  • People come first at Ferring
    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 supporting 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 continuously and close the process when we find the right match.

    For any questions, please reach out to director Mette Sonne at +45 28 78 73 12.

    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.

    Location:

    Ferring Denmark

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