Senior Manager of Regulatory Affairs
Fujifilm
Join Our Leadership Team: Senior Manager, Regulatory AffairsAt Fujifilm Diosynth Biotechnologies, we are on a mission to advance tomorrow’s medicine. As a rapidly expanding biotech company, we manufacture the leading biological products that shape the market today and the future. We are seeking an experienced Senior Manager of Regulatory Affairs who embodies our values of innovation, dedication, people fundamentals, and passion for the patient.Your RoleAs a Senior Manager in Regulatory Affairs, you will be at the forefront of our site expansion projects in Denmark and potentially in the US. You will help our customers progress their filings, but also help them view things from a different perspective. Your expertise will guide us through regulatory landscapes governed by authorities such as DKMA/EMA, FDA, and many others. You’ll lead a team of four dedicated professionals while maintaining hands-on involvement in critical regulatory activities. Further you will be part of the global regulatory affairs leadership team. Sustainability is at our heart and you will participate in such projects to ensure regulatory points/impacts are considered when finding the best solutions.In the day-to-day job you understand how to build relations, interlink with stakeholders and speak up when needed, but most of all earn the trust of your people and partners through hard work and a smile. You will be the primary contact for our commercial team and thereby be close to the news regarding new customers. Through other organizations (industry groups) you will participate in shaping the future regulation with data and knowledge.You and the team will be responsible for:
The Team You Will LeadYou will be part of and lead a great, dedicated and self-managed team of competent colleagues. The team consist of 4 experienced individuals covering a variety of tasks within Regulatory Affairs, they are driven by curiosity, humor and commitment to the patient. The team supports each other and help where we can. The team expects you to spend most of your time acting as a sparring partner for the team and less time on leading the team. Said in other words you’ll be an expert min 50% of your time and have your hands on assignments together with the team.Who We Are Looking ForWe value humor, knowledge, independence alongside teamwork skills, people fundamentals, and leadership qualities. You should have:
Why Join Us?FUJIFILM Diosynth Biotechnologies is not just another workplace; it’s a place where your passion can fuel progress. We offer opportunities for professional growth within a global community committed to diversity and inclusion. Our competitive compensation package reflects our commitment to being an employer of choice.
Your applicationIf you’re ready to take on this pivotal role within FUJIFILM Diosynth Biotechnologies and help us reimagine healthcare’s potential, please upload your CV and cover letter as soon as possible. Interviews will be conducted on an ongoing basis.Working at FUJIFILM Diosynth Biotechnologies Hillerød, Hovedstaden
Wed, 03 Jul 2024 02:34:30 GMT
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