At Astellas, experience is coupled energised with a relentless challenger spirit.

We are unusual in our ability to combine the experience, expertise and resources of an established company with the agility, flexibility and tenacity of a start-up. Relentless curiosity and a hunger for discovery flows throughout our entire organisation.

We harness the latest technology and insights from big data with our research expertise to create powerful solutions that could transform the way doctors and nurses treat and care for their patients. We are accelerating product development, driving operational efficiencies and gaining a better understanding of the needs of patients and their healthcare providers.

We partner and collaborate with academic research institutes and biotechnology companies who share our passion for bringing breakthrough discoveries to patients.

About This Job

• Contribute to preparation, compilation and transmittal of CMC submissions according to the defined schedules and meet both Health Authority and Astellas established SOPs / guidance.
• Contribute to the regulatory impact assessment of proposed CMC changes and monitors the progress of the CMC changes with regulatory impact.
• Ensure proper CMC document, including version control and metadata, and dossier management
• Support the CMC RA colleagues on assigned products and be accountable for the delivery of all assigned regulatory activities, including IND/CTA, original BLA/MAA, agency background packages, post-approval submissions/variations and responses to health authority questions per established business processes and systems.
• Identify, communicate and escalate potential issues to CMC RA Scientific Lead
• Contribute to collecting, interpretation, archiving, and knowledge sharing of regulatory requirements for both BLA/MAA and post-approval submissions.
• Develop an understanding of regulatory affairs and apply this understanding to the benefit of the company to ensure approval, product launch, and maintenance of market supply of our company's human medicinal products worldwide.
• Conduct all activities with an unwavering focus on compliance, including staying current on all training.
• Carry out all assignments to the standards of efficiency, innovation, accuracy and safety in accordance with company and regulatory requirements.
• Additional activities may be assigned by the supervisor. 

Essential Knowledge & Experience

• Bachelor’s (minimum) or graduate degree (preferred) in chemistry, biology, engineering, or a related field. Fields of study include Chemistry, Pharmacy, Chemical Engineering, Biology, Microbiology, or Biochemistry or other similar scientific discipline.
• At least three (3) years of relevant experience in regulatory CMC, or biological or vaccine research, manufacturing, testing; or related fields for candidates with a Bachelor’s degree or 1 year with a graduate degree.
• The ideal candidate must have the ability to critically review detailed scientific information and assess whether technical arguments are presented clearly and conclusions are adequately supported by data.
• The ideal candidate must have strong organizational skills with the ability to combine information from different systems
• The candidate must be proficient in English; additional language skills are a plus.

Preferred Knowledge & Experience

• Experience in biologics, cell/gene therapy or vaccines preferred.
• Knowledge of FDA/EMA, ICH regulations and guidelines (and beyond), and the ability to provide interpretations of that information to others.

Educations/Qualifications

• Bachelor in Science

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.