Senior Manager of Regulatory Affairs

Join Our Leadership Team: Senior Manager, Regulatory Affairs
At 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 Role
As 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:

• Providing insights on authority (DKMA/EMA and FDA) expectations in relation to site expansion projects
• Planning, preparing, and executing expansion and other meetings with the authorities
• Regulatory Intelligence
• Maintenance of the site master file, site licenses, and 3.2.A.1 part of customer filings
• Maintenance of US Establishment registration / FMA Japan
• Supporting customer filing activities (Pre & Post filing)
• Other customer regulatory interactions
• Regulatory part of KojoX/ ONE FDB

The Team You Will Lead
You 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 For
We value humor, knowledge, independence alongside teamwork skills, people fundamentals, and leadership qualities. You should have:

• A BSc/MSc degree in natural/life sciences.
• Over 10 years of experience in Regulatory Affairs/QA within pharma/biotech (EU & USA).
• A good portion of experience with regulatory and GxP requirements in EU & USA.
• Proven ability to manage complex cases and stakeholder relationships.
• You are good at and like to work with people and stakeholders.
• Proven leadership experience.

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 application
If 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
We offer a competitive compensation package in a site/company growing rapidly, with many opportunities for individual growth, we also offer access to fitness and an attractive canteen.

FUJIFILM Diosynth Biotechnologies is an industry-leading Biologics Contract Development and Manufacturing Organization (CDMO) with locations in Hillerød, Denmark, Teesside, UK, RTP, North Carolina and College Station, Texas, USA. We use our skills, dedication and ambition to enable impact for the world’s most innovative biotech and biopharma companies reimagining healthcare’s potential. We work across the entire lifecycle of our customers’ products – enabling success throughout. Every cure, vaccine, biologic, and advancement we contribute to starts with our people and our passion. We fuel one another’s passion, help accelerate progress, expand capabilities, strengthen innovation, and improve processes to improve lives.

Our Manufacturing site in Hillerød, Denmark, brings together a complete range of expertise, capabilities and technologies to manufacture advanced biologics. As we continue to enhance and expand our capabilities, we are looking for people who share our passion, drive, and energy – what we call Genki – to join our team.

We offer the chance to be part of a global workplace where passion, drive and commitment are met with opportunities for professional and personal development. Deeply committed to diversity and inclusion, we ensure that everyone no matter their background or gender has an opportunity to develop. We take pride in enriching our communities, caring for our environment, and cultivating a world of opportunity for future generations.

We aim to foster a collaborative, innovative and rewarding environment, where diverse perspectives and people come together united by a common purpose and shared values. We pursue our fullest potential as individual contributors and team members. We strive to be the employer of choice and offer a competitive compensation and benefit package.

FUJIFILM Diosynth Biotechnologies Denmark (FDBD) is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, sexual orientation, gender identify or any other protected class.

All agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.

Location: FDBD Hillerod