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Astellas Pharma Senior Associate, Regulatory Operations in San Francisco, California

Why Work for Us

Are you ready to use your experience and expertise to make an impact on patients' lives? Astellas Gene Therapies is a biotechnology company developing new genetic medicines for rare, life-threatening diseases. We are working urgently to progress our medicines and need additional team members to help us do so. Because our mission is so important, our values are to: Be BOLD: Find a Way, Care Deeply, and Get Stuff Done. If you'd like to be a part of this important mission, please apply to join our team.

About Astellas Gene Therapies

Astellas Gene Therapies is developing genetic medicines for patients with rare, life-threatening diseases. Based on our innovative approach to developing genetic medicines, as well as our industry-leading internal manufacturing capability and expertise, we have become the Astellas Center of Excellence for the newly created Genetic Regulation Focus Area. We are currently exploring three gene therapy modalities: gene replacement, exon skipping gene therapy, and vectorized RNA knockdown, with plans to expand our focus and geographic reach under Astellas. We are based in San Francisco, with manufacturing and laboratory facilities in South San Francisco and Sanford, North Carolina.

Our Values:

  • Be BOLD (Find a Way)

  • Care Deeply -- for our patients, each other and our work

  • #GSD (Get Stuff Done)

What is the catalyst for you in your professional career? Are you ready to be a part of a bold, innovative company, to make a change and to make a difference? Listed below is a current opening for a smart, driven, experienced, and just plain nice individual who wants to join us and be a part of our journey.

The Role

The Senior Associate of Regulatory Operations plays a vital role in our Regulatory Affairs team. This role provides publishing support to facilitate accurate and timely formatting and preparation of Word and PDF documents associated with non-clinical studies, clinical studies, and all documents designated for regulatory submissions, conforming to the electronic Common Technical Document (eCTD) format, and other submission standards as specified by FDA, ICH, and ROW guidelines.

The ideal candidate would be able to independently support Regulatory Affairs in the timely formatting, publishing, finalization, submittal, and archiving of all documents intended for submission to global health authorities. This position reports to the Associate Director of Regulatory Operations, and will be based in our San Francisco office. This position does not have any direct reports but must be able to operate effectively with limited authority.

Primary Responsibilities

  • Coordinate and perform formatting, publication, and submittal of regulatory submissions, as assigned by Manager or head of Regulatory Operations.

  • Compile and perform hyperlinking of electronic submissions using LORENZ docuBridge and associated publishing tools.

  • Ensure final document components are electronically archived according to departmental practices.

  • Interface with Regulatory Affairs team members to regarding submission planning, templates, and publishing.

  • May assist and/or provide training to others on software tools used and educating authors on publishing policies and procedures.

  • Review source documents for use related to eCTD compliance and provide formatting suggestions to create eCTD-ready documents as needed.

  • Provide training, technical support, and coordination for Regulatory team members, as necessary, throughout the process of creating eCTD-compliant PDF report compilations, including document troubleshooting and use of software.

  • Organize and track all documents designated for major and minor submissions.

  • Support the organization in maintaining a work environment focused on quality and that fosters learning, respect, open communication, collaboration, integration, and teamwork.

About you

Must Have/Required

  • 3+ years of Regulatory Publishing experience in the pharmaceutical or biotechnology industry.

  • Experience with publishing and submission of dossiers in eCTD and non-eCTD format.

  • Advanced computer skills, specifically in Microsoft Office Word formatting and style templates, Adobe Acrobat, IQVIA PDF Tools or DXC Toolbox, and LORENZ docuBridge.

  • Excellent oral, written, and interpersonal skills.

  • A superior multi-tasker, highly organized and successful in a fast paced, changing environment.

  • Demonstrated attention to detail and consistent ability to operate with accuracy and quality.

  • Ability to master new technical skills and apply them to projects as the industry, and the company, evolves.

  • Works well under general direction, with the ability to independently determine and develop approaches to non routine problems following established departmental best practices.

  • Models our Core Values: Be Bold: Find a Way, Care Deeply, Get Stuff Done -- is experienced as someone who exemplifies the culture we want to create; operates with transparency; is trusted

May Have/Preferred

  • Working knowledge of electronic document management systems (EDMS) and Regulatory Information Management Systems (RIMS), including Veeva Vault RIM

  • Working knowledge of computer systems validation and assistance in implementation or maintenance of RIMS Systems and Processes

  • Bibliography and literature management software such as EndNote, Reference Manager, etc.

  • Experience with rare diseases, neuromuscular diseases and/or gene therapy products

  • Experience in a small company and high growth, fast-paced environment

#LI-LK

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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