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At Astellas, we strive to become a cutting-edge, value-driven life science innovator. This means working at the forefront of healthcare change to turn innovative science into VALUE for patients.
What sets us apart is our focus on patients, our pioneering innovation, our collaborative culture, and the passion of our talented people.
Making a positive impact on patients’ lives is the purpose behind everything we do. At Astellas, we are relentless in our pursuit of scientific progress and in tackling unmet medical needs, demonstrated by our legacy in oncology, overactive bladder and transplant and our impressive pipeline in women’s health, blindness and regeneration, genetic regulation, immuno-oncology, mitochondria and targeted protein degradation.
About Us:
We are a global pharmaceutical company headquartered in Japan, with a team of more than 14,000 managing operations in approximately 70 countries around the world. We are in the Top 30 global biopharma company based on global revenues and are predicted to be one of the Top 10 Cancer Drug Makers of 2024 by Fierce Pharma.
In Canada, we are growing to meet the exciting opportunities realized by our legacy brands and rich pipeline of innovative treatments.
We are looking for candidates who will thrive in our entrepreneurial and empowering environment where talent and leadership flourish. Do your values align with our Astellas Way – patient focus, ownership, results, openness and integrity? Then we would love to hear from you.
From the first day in role, everyone at Astellas has a responsibility for creating a brighter future for patients around the world. We nurture exceptional relationships with our employees to allow them to thrive, foster innovation, and deliver exceptional business results. We work to create a culture where our people feel empowered to pursue brave ideas and ambitious outcomes, to have the confidence to be accountable for a higher standard of performance and embody a competitive and solutions-oriented mindset.
Our expertise, science and technology make us a pharma company. Our open and diverse culture is what makes us uniquely Astellas.
Astellas Pharma Canada (APCA) is currently searching for a Partner, Regulatory Affairs Product Information Management.
Description
Responsibilities include organizing regulatory operations aspects of projects/products, including – managing the planning, tracking of applications and other structured data to regulatory agencies, – identifying and ensuring adherence to relevant submission standards, – initiating/maintaining relationships with key personnel within the global Regulatory Affairs organization to resolve procedural and operational complexities and identify process improvements. The position also involves strategic and execution-focused interactions with multiple regional health authorities and other Astellas functions such as Pharmacovigilance, Marketing Operations, Data Science, Supply Chain, Manufacturing and other areas within Medical & Development. The Senior Manager also serves on increasingly more significant project teams/task forces.
Essential Job Duties
Organizational Context
Required Qualifications
Preferred Qualifications
Additional Information
Astellas Pharma Canada welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the hiring process.
Astellas Pharma Canada requires full Vaccination against COVID-19 as a condition of employment. Reasonable accommodation to this policy may be granted for a valid accommodation request under human rights legislation.
No telephone inquiries, in-person applications, or agencies please. While we appreciate all applications, only candidates under consideration will be contacted.
Category Established Markets Global Op
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans
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