General Information

Job Advert Title
Mgr, Regulatory Affairs
Location
Japan, Netherlands, United States
Function/Business Area
Regulatory Affairs
Department
CMC RA
Employment Class
Permanent

Description

CMC regulatory affairs manager


About Astellas:

        

At Astellas we can offer an inspiring place to work and a chance to make your mark in doing good for others.Our expertise, science and technology make us a pharma company. Our open and progressive culture is what makes us Astellas. It’s a culture of doing good for others and contributing to a sustainable society.Delivering meaningful differences for patients is our driving force. We all have a significant opportunity to make that difference, working locally in the areas we know best, whilst drawing inspiration from the different insights and expertise we have access to globally and from our innovative, external partners.

Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience. At Astellas, Patient Centricity isn’t a buzzword - it’s a guiding principle for action. We believe all staff have a role to play in creating a patient-centric culture and integrating an awareness of the patient into our everyday working practices, regardless of our role, team or division.

Our ethos is underpinned by the Astellas Way, comprising five core values: patient focus; ownership; results; openness and integrity.We are proud to offer an inclusive and respectful working environment that fosters collaboration and ownership.Our aspiration is to bring the best brains together, to provide them with world-leading tools and resources and a unique structure that fosters real agility and entrepreneurial spirit.


About This Job:


Due to changes in the environment in the pharmaceutical industry, CMC fields of regulatory affairs are becoming more important. There is a need in this field for capability to understand the characteristics of multiple modalities of drugs and the latest regulatory requirements, to realize expedite submission and approval globally with optimal regulatory strategies, and to efficiently maintain the products on the market in post approval stage. We are recruiting a new member who works with us in this field and contribute to bringing our products to patients all over the world.


  • Responsible for overall CMC regulatory activities throughout development, NDA and post approval  CMC change globally, mainly for biologics.
  • Establishing CMC regulatory strategy for regulatory submissions.
  • Communication and collaboration with relevant departments for preparation of CMC sections of regulatory dossier, and the document review.
  • Coordination of cross functional discussion for CMC section of regulatory dossier.
  • Maintenance of CMC approval contents globally.
  • Dealing with information request from HAs and other CMC issues.

Essential Knowledge & Experience:


  • BS in Biochemistry/Chemistry/Pharmaceutics or equivalent degree
  • Extensive experience in CMC or regulatory area, or equivalent experience.
  • Experience or expertise sufficient to support documentation of regulatory dossiers of biologics products (gene recombinant protein and antibody).
  • Knowledge on CMC regulations (ICH Guidelines, Standards for biological materials, etc.) and basic

Preferred Educations/Qualifications:


  • Experience of ATMP (cell and gene therapy) or Vaccine products development in CMC Regulatory Affairs
  • Experience of communication with broad global stakeholders

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.