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Astellas Pharma Senior Regulatory Operations Associate in Northbrook, Illinois

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com .

This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.

Purpose and Scope:

  • This job description applies across the three sub-sections within Regulatory Operations: Regulatory Product Information Management, Publishing & Submission, and Data Integration and Optimization. The Senior Associate is expected to be a specialist in at least one of these key areas.

  • Responsibilities will include timely preparation and submission of correspondence and applications to regulatory agencies, tracking and planning of those submissions, conformance to global publishing standards and implementation of process and technology changes for regulatory systems.

  • Interacts on regional and global projects with other areas of the Astellas organization, sometimes including regional health authorities.

Essential Job Responsibilities:

  • Ensure timely planning, preparation, delivery and tracking of correspondence and submission packages to regulatory agencies

  • Responsible for timelines and own resource management. Participates in extended teams/projects/teams. Ensures timely internal communication regarding regulatory filing status.

  • Is considered a specialist in the field of electronic document management, submissions management & publishing or regulatory information management. Is involved in implementation of process and technology changes for regulatory systems.

  • Member of Astellas project teams / task forces. Is considered a regulatory operations expert by the project teams/task forces.

  • Provides advice on technical quality of submission ready documents and completeness of planning and tracking information.

  • Ensures compliance with Regulatory Agency rules and guidelines pertaining to regulatory submissions in all required formats.

  • Represents Regulatory Operations in local project teams.

  • Ongoing maintenance of process documentation associated with Regulatory Operations activities.

  • Act as a liaison between members of Regulatory Affairs, QA and Operations in order to ensure timely submission of regulatory compliant, quality documents.

  • Participates in the global testing and piloting of new electronic software tools (to include version upgrades), and submission types.

  • May supervise contract staff in the conduct of their duties. Conduct trainings for new users in Regulatory systems and creates job aides, process improvements, and training documentation.

Quantitative Dimensions:

Globally Reg Ops supports electronic and paper submissions for over 400 applications in over 100 countries. Globally the Regulatory Product Information Management group supports approximately 3,000 -- 3,500 requests of data entry for Regulatory Information Management system.

Organizational Context:

  • The Regulatory Operations Senior Associate reports a Manager, Senior Manager, Associate Director or Director of Regulatory Operations.

  • Line manager will be in the same geographic location to the extent possible.

  • No line manager responsibility.

  • Reg Ops staff are expected to be flexible and willing to work on assignments in any of the three areas based on ability, professional development 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

Qualifications:

Required

  • At least one years' experience in the pharma industry with some experience in a regulatory operations role

  • Proven ability to prioritize and multi-task with minimal supervision based on interactions with project team members

  • Strong ability to communicate effectively in writing and verbally in English

  • High integrity with respect to maintenance of proprietary, confidential information.

  • Demonstrated accomplishments and/or education will be evaluated and substituted for extent of experience, as needed

Preferred

  • Bachelor's degree (science or technology is preferred)

  • 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 concepts

  • 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

Benefits:

  • Medical, Dental and Vision Insurance

  • Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down

  • 401(k) match and annual company contribution

  • Company paid life insurance

  • Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions

  • Long Term Incentive Plan for eligible positions

  • Referral bonus program

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Category Medical and Clinical Development

Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans

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