Partner, RA Regulatory Product Information Management

Purpose and Scope:

Summarize the primary purpose of the position in 1-3 sentences. Intent is to capture the work this position does and is accountable for and why the role exists as a unique position. Not intended to be a summary of all duties.

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.

Responsibilities and Accountabilities:

• Supports the accuracy and completeness of global regulatory product data, metadata and other regulatory information in collaboration with data owners by 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)

• Performs or oversee one or more aspects of 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

• Contributes and collaborates with RA stakeholders in order to provide regulatory information to other systems inside or outside of RA according to system integration logic

• Identifies opportunities to align vocabulary management across RA systems, in conjunction with the Data Governance and Compliance team
• Designs ad tests reports sharing Regulatory information with cross-functional stakeholders including Pharmacovigilance, Medical Affairs, Development Operations, Finance and senior and top management
• Supports the generation and transmission of data-centric regulatory submissions such as XEVMPD and IDMP

Required Qualifications:

• Bachelor's degree (science or technology is preferred)
• At least three years' experience in the pharma industry with some experience in a regulatory operations role
• Demonstrated accomplishments and/or education will be evaluated and substituted for extent of experience, as needed
• Ability to work independently with minimal direction and 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
• 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
  Ability to keep calm under pressure

Preferred Qualifications:

Advanced degree (e.g., Masters, PhD, etc,)

At least six years' experience in a regulatory operations role or similar

• Experience with managing IT systems or providing business operational support
• Experience using document management, submission publishing, registration management, labeling 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

Working Environment

Choose one of the first two statements below to describe onsite work expectations for the role. Additional points may include travel requirements, office or laboratory working environment, highly collaborative environment, description of equipment used, etc.

At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas' Responsible Flexibility Guidelines.

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