Senior Manager, RA Regulatory Product Information Management

Senior Manager, RA Regulatory Product Information Management   #24-POS00000450M

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Job Description

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.

• Supports the accuracy and completeness of global regulatory product data, metadata and other regulatory information in collaboration with data owners by authoring and/or reviewing the quality documents and other reference material and that adhere to the relevant data standards and industry best practices (i.e. Data Steward role)
• Supports the daily operation of the global Regulatory Information Management system including data entry, quality control and metrics
• Supports and creates business processes to capture/track regulatory events/information into regulatory database according to local regulatory requirements
• Supports for ensuring regulatory information is provided to systems inside or outside of RA according to system integration logic
• Supports controlled vocabulary management across RA systems, in conjunction with the Data Governance and Compliance team
• Delivers reports sharing Regulatory information with cross-functional stakeholders including Pharmacovigilance, Medical Affairs, Development Operations, Finance and senior and top management
• Oversees the process and ensures the creation and transmission of data-centric regulatory submissions such as XEVMPD and IDMP

 Organizational Context

• Reports to Team Lead RA Regulatory Product Information Management
• Line manager may be in another geographic location
• Peers are other global Regulatory Operations staff to promote sense of one Reg Ops team.
• Reg Ops staff are expected to be flexible and willing to work on assignments in any of the three areas based on ability and business need.
• Globally the Reg Ops group has approximately 30 internal staff members which is supplemented by a small number of vendors providing the service-based equivalent of another 20-30 FTE.

Requirements

Required Qualifications

• Bachelor’s degree (science or technology is preferred)
• At least five years’ experience in a regulatory operations role or similar position associated with regulated processes and content in the pharma industry
• Demonstrated accomplishments and/or education will be evaluated and substituted for extent of experience, as needed
• Ability to work independently with minimal direction and coordinate priorities and tasks within project teams, committees, etc. to attain group goal
• Proven ability to prioritize and multi-task with minimal supervision based on interactions with project team members demonstrate the ability to do so
• Ability to communicate effectively, establish and maintain productive working relationships, and influence peers and others in the organization
• Strong ability to communicate effectively in writing and verbally in English
• Ability to multi-task across multiple projects and deliverables
• High integrity to maintain confidential and proprietary information

Preferred Qualifications

• Advanced degree (e.g., Masters, PhD, etc,)
• Experience with managing IT systems
• Demonstrated proficiency using registration management, labeling, quality control and/or change control systems
• Basic understanding of information taxonomies, master data management or other structured data constructs
• Basic understanding of data warehousing, data lakes and reporting/analytics platforms or concepts
• Proficiency in other language(s) – most common/useful are Dutch, Japanese, Spanish, Portuguese, French, Russian, Chinese

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.