Senior Global Regulatory Affairs Manager

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? Ferring + you Our Global Regulatory Affairs CMC Biologics team is expanding to support ongoing development activities, market expansions, and lifecycle projects for our newly approved gene therapy product.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.

You can look forward to share ideas and strategies with your fellow CMC colleagues.

“At Ferring, you don’t need to have been in the organization for many years to make a difference for our products and influence our processes. You can apply your experience pretty much from day one” Director Mette Sonne explains.

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

Most of your time will be spent contributing to a cross-functional team, representing regulatory CMC, working alongside highly skilled and equally dedicated colleagues. Drawing on your experience with advanced therapy medicinal products, you will:

• Act as a senior 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 Pharma Science 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.

More specifically, we are looking for:

• More than 8 years of solid experience in Global Regulatory Affairs CMC focusing on advanced therapy products/biologicals.

• Experience in facilitation of risk management discussions

• A degree as M.Sc. in life science or pharmacy

People come first at FerringOur 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 youIf 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. Location- Ferring Denmark.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. Note to agencies: This search is being managed by Ferring’s Talent Acquisition team. Kindly do not send us unsolicited profiles.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. Read more at ferring.com.

Location:
Ferring Denmark