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Astellas Pharma Associate Regulatory Affairs Manager 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:

Responsible for oversight and/or development of regulatory submissions and required to effectively interact with members of the project/product team or extended regulatory team . Works independently on day-to-day interactions with the project/product team. Initiates planning for new assignments with management oversight/guidance. Responsible for the coordination of regulatory submissions staff as appropriate. Uses technical expertise gained from regulatory affairs and other pharmaceutical industry training/experience to meet objectives.

Essential Job Responsibilities:

  • Completes regulatory tasks on projects and/or products related regulatory submissions and advises on the preparation, review and submission to regulatory agencies with supervision

  • of a Group, Team, Global and/or Regional Regulatory Lead Represents Regulatory Affairs on local project teams and extended regulatory teams for routine projects/products

  • Effectively interacts with project/ or product and regulatory teams to define an appropriate submission strategy for new submissions and to support existing regulatory registrations including life cycle management with support from senior regulatory staff Contributes to the development of regulatory strategies with oversight from more senior RA members

  • Interprets and applies regulations and guidance to ensure compliance with regulatory Submissions

Quantitative Dimensions:

Incumbent will interact with a wide range of departments and position levels, including but not limited to Global Regulatory Affairs, Global Development, Global Pharmacovigilance and Technology Division. Maintains all assigned projects/products as compliant with regulations and guidelines. Addresses issues that arise in project/products teams that impact areas of responsibility. Actively identifies and escalates issues requiring solution while informing the necessary audience of the challenges and advantages of proposed solution. Position has direct impact on the company's ability to meet goals and timelines related to the regulatory submissions.

Organizational Context:

  • Position reports to a Group Lead or Team Lead Development and/or Life Cycle Management.

  • Position above is a Manager, below is a Senior Associate

Qualifications:

Required

  • Bachelor's degree or equivalent; scientific discipline preferred

  • 3-4 years related work experience desired in industry or similar healthcare related field with 1-2 years regulatory affairs experience preferred

  • Demonstrated experience with compilation of and compliance with regulatory submissions

  • Experience writing submission ready regulatory documents

  • Scientific knowledge in chemistry, general biological/physical science and ability to apply that knowledge to regulatory issues and product development

  • Good organizational skills with the ability to manage projects

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

  • Good communication, organization and negotiation skills, including written skills, to meet regulatory requirements and standards

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 Regulatory Affairs

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

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