Senior Associate, Regulatory Affairs

at  Fujifilm Diosynth Biotechnologies

About Us
At Fujifilm Diosynth Biotechnologies, we’re committed to advancing tomorrow’s medicine. As a fast-growing biotech company, we are at the forefront of developing and manufacturing the leading biological products in the market. Join us and become a part of a company that strives to be the leading CDMO within our areas of expertise.
The Role
We are seeking a dedicated and experienced Senior Associate for Regulatory Affairs. As part of our team, you will play a critical role in our site expansion projects and ongoing compliance initiatives. You will represent Regulatory Affairs in site expansion projects, offering insights into DKMA, EMA, and FDA expectations. You will assist in planning and executing meetings with these authorities, acting as a liaison to facilitate smooth communication and project progression. You will work in close collaboration with our commercial and operational teams to provide guidance on manufacturing flexibility while minimizing regulatory impacts for our customers.
You will also support the maintenance of the site master file and site licenses, relevant eCTD documentation, regulatory intelligence and help current customers maintain their filings worldwide. The role will include participation in industry groups to help shape future regulation. By engaging with these organizations, you will bring back valuable insights and contribute to regulatory strategies that benefit our organizational goals.
The role includes providing regular updates to the Quality Leadership Team and other stakeholders on regulatory trends, changes, and challenges. This includes communication of consequences of regulatory options and decisions, ensuring stakeholders are informed and engaged.
Sustainability and innovation are central to our mission. You will contribute to projects that integrate regulatory considerations into sustainable solutions, helping us achieve our long-term objectives in a responsible manner.
The Team
You will be part of a great, hard-working, and self-managed team of competent colleagues. We are a team of 4 experienced individuals covering a variety of tasks within Regulatory Affairs, we are driven by our curiosity, humor, and commitment to the patient. We support each other and help where we can.
Qualifications
A person with a good sense of humor and charm, who can work independently, be a team player when it is needed and a leader. You have strong background within Regulatory Affairs and/ or QA and understand how one impacts the other. A good portion of experience with regulatory and GxP requirements in EU & USA. You are good at and like to work with people and stakeholders.

You must have:

• BSc/MSc in natural or life sciences.
• Over 10 years of experience in Regulatory Affairs/QA within the pharma/biotech industry, with specific expertise in EU & USA regulations.
• Strong knowledge of GxP requirements and regulatory frameworks.
• Proven ability to manage and communicate complex cases and stakeholder relationships.
• Excellent communication and interpersonal skills to engage with diverse teams and external partners.

Why Join Us?
Fujifilm Diosynth Biotechnologies offers a vibrant workplace that encourages innovation and personal growth. With a commitment to diversity, inclusion, and an industry-leading compensation package, we make sure your career with us is both rewarding and progressive.
If you’re passionate about making a difference and ready to take on this exciting opportunity, apply with your CV and a cover letter. We conduct interviews on a rolling basis, so apply soon!
Fujifilm Diosynth Biotechnologies is an Equal Opportunity Employer.
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 site in Hillerød, Denmark, brings together expertise, capabilities, and technologies to manufacture advanced biologics. The large-scale manufacturing facility has a capacity of 120,000 liters to reliably manufacture biologics for late phase and commercial use. We commenced 6 billion DKK projects to double our manufacturing capacity and to add fill finish to the site.
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. 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.
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.
To 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.
About Us
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 site in Hillerød, Denmark, brings together expertise, capabilities and technologies to manufacture advanced biologics. The large scale manufacturing facility has a capacity of 120,000 liters to reliably manufacture biologics for late phase and commercial use. We commenced 6 billion DKK projects to double our manufacturing capacity and to add fill finish to the site.
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.
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.

Please refer the Job description for details