Associate, Global Regulatory Affairs

US-IL-Chicago
1 month ago
ID
2017-1988
Adello Biologics, LLC

Overview

Adello Biologics is a privately held, U.S.-based biotechnology company that leads with science to accelerate development and drive manufacturing efficiency. The company's aim is to provide high-quality, affordable biosimilars to patients worldwide. Headquartered in Piscataway, NJ and driven by a team of highly skilled industry veterans, Adello is advancing a strategic pipeline of proteins and complex monoclonal antibodies with lead candidates in oncology and immunology. For more information, visit www.Adellobio.com

 

Our vision is to make biosimilar medications affordable. We are seeking candidates interested in contributing to a bourgeoning field that has the potential to help millions of patients. As a growing company, Adello Biologics offers real development opportunities for candidates excited to take on responsibility, make an immediate impact and help us achieve our vision. As part of a close knit team, you’ll have the opportunity to work in a unique, high science industry while expanding your career. We are seeking an Associate, Global Regulatory Affairs to be based out of our Chicago, IL location.

 

Responsibilities

 

SUMMARY:

Associate, Global Regulatory Affairs is a regular employee in a full-time exempt position at Adello Biologics, LLC, in Chicago, IL. This position will be directly responsible for preparation, publishing and filing of biosimilars marketing applications for products in global markets. The individual will work collaboratively and proactively within the regulatory team and across multiple functional areas to assist with implementation of the strategy, scope, and content of sections of US and Global marketing applications.

 

Essential Duties and Responsibilities:

  • Understand and interpret regulations, guidelines, procedures, and policies relating to the development, manufacture, and successful global registration of biologics and biosimilar products.
  • Compile multiple regulatory dossier components for submission, to meet project timelines.
  • Review and edit documents/dossier components to assure technical/regulatory requirements and data integrity/data verification processes are followed.
  • Ensuring dossier components meet global/regional standards for content, quality, and regulatory requirements for final review and sign-off by Regulatory Affairs.
  • Work closely with regulatory team to produce high quality submissions. Work closely with project management and regulatory team assist in completion of assigned project objectives through efficient activities within designated time frames.
  • Flexible to adjust plans to deal with changes, obstacles and offer alternative pathways for completion of projects.
  • Identify, document, and communicate regulatory project risks and delays to senior regulatory staff regarding issues that could impact timelines and quality of regulatory submissions.
  • Organize and archive dossier components and supporting documents in appropriate document management systems (i.e. Documentum, Master Control, eCTDXpress, etc).
  • Coordinate dossier review, approval and publishing activities.
  • Other tasks as requested by management.

Qualifications

PREREQUISITES:

Education:

  • A Bachelor’s degree in life sciences or related scientific discipline.

Experience:

  • 3-4 years of experience working in a scientific field.

 

SPECIALIZED KNOWLEDGE AND SKILLS:

  • Must be able to speak, read, and write fluently in English.
  • Strong technical writing skills and attention to detail.
  • Strong verbal communications skills and demonstrated ability to work in a matrix/team environment.
  • Ability to prioritize and coordinate multiple tasks and adjust to changing priorities to deliver results to tight deadlines.
  • Strong computer skills in Microsoft Office applications with the ability to learn new applications quickly and easily.
  • Basic knowledge of regulatory requirements.
  • Understanding of dossier development and formatting requirements, document and dossier management.
  • Computer proficient in MS Word (to include use of ISI Writer templates) and Adobe Acrobat.
  • Experience with document publishing and eCTDXpress publishing software, or ISI ToolBox a plus.
  • Experience with electronic document repository platforms such as Documentum, a plus.
  • Have effective oral and written communication skills.
  • Understanding of components / requirements for an IND, CTA, NDA, BLA, eCTD, ICH and FDA guidance, particularly as it relates to electronic submissions and publishing.

 

WORK ENVIRONMENT AND PHYSICAL DEMANDS:

  • Significant amount of time sitting while doing computer work.
  • No special weight lifting requirement.
  • Limited travel may be required, not to exceed 10%.
  • Able to work extended hours or on weekends, as may be required.

 

Adello Biologics, LLC provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, Adello Biologics, LLC complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, and transfer, leaves of absence, compensation and training.

Notice To Agency And Search Firm Representatives

Adello Biologics is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Adello employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Adello. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

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