(Senior) Global Regulatory Affairs Manager – CMC

Job title:

(Senior) Global Regulatory Affairs Manager – CMC

Company:

Ferring

Job description

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.Ferring + youWe look forward to welcoming you to our Global Regulatory Affairs CMC department, where you will be surrounded by about 30 highly skilled and dedicated colleagues.The department comprises regulatory managers/leads responsible for our approved products, development projects, and medical devices. Together, we represent expertise within the fields of 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 FerringCollaborating with stakeholders (e.g., manufacturing sites, QA, and the supply organization), project teams, and colleagues within Regulatory Affairs, your primary focus will be lifecycle activities for a well-established product within the Small Molecules team. Depending on your experience level, you may also contribute your expertise to a product in the early phases of development.Your main role will be to:Take responsibility for the CMC part of regulatory submissions and approvals for worldwide market expansionsProvide regulatory CMC strategies and expertise to cross-functional teams such as global regulatory project teams, CMC teams, product teams, and launch teamsPerform regulatory impact assessments of CMC changes the established products/ drug substances and potentially for the development projectsEnsure adequate documentation is generated, submitted, and approved on time worldwideDrive and execute scientific advice with national Competent Authorities concerning CMC activitiesParticipate actively in the development and optimization of our departmental and working processesWhile you can work from home up to two days a week, your primary work location will be our state-of-the-art International PharmaScience Center (IPC) in Copenhagen. Here, you can take a break by enjoying the incredible ocean views – or even join some of your colleagues when they take a swim.Behind our innovation – there’s youWe are looking for a colleague who can independently run variations and act as a representative for GRA CMC in project teams. With your understanding of the regulatory requirements, you can weigh in when determining the best strategy for any given project.To do so, you will need:M.Sc. in life science or pharmacy+3 years of experience in global regulatory affairs (preferably within regulatory CMC activities and development projects)

+7 years of experience from a similar global RA position (for Senior position)Proactive mindset and a desire to find innovative solutions to regulatory challengesGreat collaboration and negotiation skills – you see teamwork as the road to successYou must have a proactive mindset and a desire to continuously develop and find innovative solutions to regulatory challenges, which you are able to communicate well verbally and in writing. In addition, you are well-organized and can plan, execute and meet deadlines. You have good negotiation skills and can deal with ambiguity. You are a true team player and are keen on working in a multicultural corporate environment.People come first at FerringOur “people come first” philosophy is lived through every part of our business. We empower and support each other to achieve excellence together. Here, you are not only encouraged to speak your mind – we expect you to do so.As a company, we are committed to supporting all employees in their career development and ensuring all our team members receive the proper support and progression. Our diverse backgrounds, experiences, expertise, and perspectives enable us to find solutions to even the most challenging problems, and our success is tied to each team member’s contributions.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.For any questions, please reach out to Martin Gabler, Global Regulatory Affairs, CMC, Small Molecules, at +45 28 78 79 72.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

Expected salary

Location

Kastrup, Hovedstaden

Job date

Sat, 09 Nov 2024 05:29:39 GMT

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