Partner, RA Regulatory Product Information Management

3 weeks ago

Markham, Canada Astellas Pharma Inc. Full time
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

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 metricsSupports and creates business processes to capture/track regulatory events/information into regulatory database according to local regulatory requirementsSupports for ensuring regulatory information is provided to systems inside or outside of RA according to system integration logicSupports controlled vocabulary management across RA systems, in conjunction with the Data Governance and Compliance teamDelivers reports sharing Regulatory information with cross-functional stakeholders including Pharmacovigilance, Medical Affairs, Development Operations, Finance and senior and top managementOversees 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 ManagementLine manager may be in another geographic locationPeers 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 industryDemonstrated accomplishments and/or education will be evaluated and substituted for extent of experience, as neededAbility to work independently with minimal direction and coordinate priorities and tasks within project teams, committees, etc. to attain group goalProven ability to prioritize and multi-task with minimal supervision based on interactions with project team members demonstrate the ability to do soAbility to communicate effectively, establish and maintain productive working relationships, and influence peers and others in the organizationStrong ability to communicate effectively in writing and verbally in EnglishAbility to multi-task across multiple projects and deliverablesHigh integrity to maintain confidential and proprietary information

Preferred Qualifications

Advanced degree (e.g., Masters, PhD, etc,)Experience with managing IT systemsDemonstrated proficiency using registration management, labeling, quality control and/or change control systemsBasic understanding of information taxonomies, master data management or other structured data constructsBasic understanding of data warehousing, data lakes and reporting/analytics platforms or conceptsProficiency 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.

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