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  • jobs
  • 1 month ago

jobs description

Do you want to join an advanced biotech company that expands exponentially to develop and manufacture the leading biological products on the market today and for the future? Then join Fujifilm Diosynth Biotechnologies, a biotech company that aspires to be the leading CDMO within our areas of expertise.

Are you proficient in regulatory guidelines beyond the average level and have Regulatory Affairs and/or QA experience? Are you interested in acting as a liaison with authorities, deal with expansion projects, customers, and internal colleagues? Do you want to participate in shaping the future regulation through other organizations? Then we have the job you are looking for! We are currently looking for an experienced colleague to join our diverse team.

The team for you to join

You will be part of a great, dedicated 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.

What would your role look like?

You will represent Regulatory Affairs in the site expansion projects, where you will provide insights on authority (DKMA, EMA and FDA) expectations. Plan, prepare and execute expansion meetings with the authorities. Be part of the liaison meetings between our commercial department/ customers, operations and the expansion projects. Provide guidance on how best to keep manufacturing flexibility with minimum regulatory impact 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. Further you will be involved in the cross site regulatory network where we exchange information, share best practices, and help each other.

Sustainability is at our heart and you will participate in such projects to ensure regulatory points/impacts are considered when finding the best solutions. Further you are an active member of such groups and you will be part of the solutions.

In the day to day job you understand how to build relations, interlink with stakeholders and speak up when needed. You will also 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.

On a regular basis you will provide updates to members of Quality Leadership Team.

Who are we looking for?

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/ Be
• BSc/ MSc degree within natural and/or life science
• +10 years of Regulatory Affairs and/or QA experience from the pharma/biotech industry (EU & USA)
• Skills to structure cases, manage stakeholders and follow up
• Ability to keep an overview while dealing with details and laying the compliance regulatory puzzle and seeing/communicating the consequences of options/decisions

Application

Are you interested? Then we urge you to please upload your CV and cover letter as soon as possible as we will be doing interviews on an ongoing basis.

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.

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
Hillerød Denmark

salary-criteria

Apply - Regulatory Affairs - Senior Specialist Hillerød