Share this Job

When it comes to life-threatening diseases, we are one family. We at Kiadis, a Sanofi company are focusing our research & development on NK cell therapeutics, leveraging the natural strengths of our immune systems to source the best cells for life. 

 

Would you like to be the pathway between our CMC activity and the Regulatory Authorities to help delivering our amazing work to patients worldwide? Are you a Regulatory Affairs expert with broad CMC knowledge and that is ready to deliver crucial strategic input? Are you a charismatic influencer that effectively manages leadership encounters with a high sense of integrity? Read on.

 

The role

As an Senior Manager Regulatory Affairs – CMC for innovative biologics including cell and gene therapy products, you are responsible , for development of the CMC Regulatory strategy and pathways, and managing development of the Regulatory Affairs plan for the different investigational products. Develop and recommend company policy and position on Regulatory Affairs issues assuring that they are aligned with Health Authority requirements. In addition, you will ensure that regulatory documents are of high quality and submitted timely.

In your day-to-day you will:

  • Represent the Regulatory Affairs department/be the Regulatory Affairs Lead in multi-disciplinary project team meetings.
  • Participate in the design of the Kiadis Pharma product strategy.
  • Liaise with Regulatory Authorities (FDA, EMA, Health Canada and/or local competent authorities) on clinical programs, ODDs, marketing authorizations and product compliance issues and ensure that the company’s activities comply with the regulatory requirements.
  • Be responsible for managing the compilation and submissions of all regulatory filings within established timeframe and schedule by coordinating filing activities between departments and local/regional regulatory groups.
  • Ensure that the company’s activities comply with US, European and other regulatory requirements together with the local/regional regulatory experts.
  • Provides CMC regulatory input to change management processes
  • Keep track of the regulatory activities and commitments in a centralized place
  • Support other departments to ensure regulatory requirements are met.
  • Maintain current knowledge of relevant regulatory requirements for drugs, ATMP’s and biological products in US, Europe and Canada.

 

The ideal candidate

We are looking for someone that wants to be part of a dynamic organization, with multidisciplinary team structures and continuous switch of prioritization. It would be great if you have the following requirements:

  • MSc, PhD or PharmD in cell biology, immunology, hematology, oncology, biotechnology, or related fields
  • 7-10 years of experience in drug development with at least 3 years in regulatory affairs.
  • Experience in the field of cell or gene therapies/ATMPs, and/or orphan drug designations is a plus.
  • Familiar with FDA, EMA, Health Canada and/or competent authorities.
  • Regulatory Affairs knowledge on CMC development.
  • Regulatory certification is a plus
  • Strong communicator both with internal and external parties.
  • Open to travel up to 10%.
  • Flexible as we work across multiple time zones.
  • Fluency in English, other languages are a plus.

 

What we offer

People from all over the world, together as one team, contribute to improving the lives of patients every day. We offer an exciting position in an innovative, dynamic and inspiring environment where you'll receive a competitive remuneration package, autonomy and the opportunity to make your own mark within the organization.

 

We create an environment where ideas are shared, experiences are impactful, and talent is developed. Because of our inclusive and family-like environment, you will always have the feeling of belonging & appreciation.

 

Kiadis Pharma is an equal opportunity employer. We understand that diversity of thought, culture and background will help us do the best for our patients. We prohibit unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status.