Lead Manager, Regulatory Affairs Operations

3 weeks ago

Marquand, Missouri, United States Sumitomo Pharma Full time

Location: Must include 'city, state' or a zip code for radius search.

Company Overview: Sumitomo Pharma Co., Ltd. is a prominent global pharmaceutical organization headquartered in Japan, with significant operations in the U.S., Canada, and Europe. Our focus is on meeting patient needs across various therapeutic areas including oncology, urology, women's health, rare diseases, psychiatry & neurology, and advanced therapies.

Position Overview: We are in search of a proactive and experienced professional for the role of Lead Manager, Regulatory Affairs Operations. This position is pivotal in managing all Regulatory Affairs functions related to the compilation, publishing, distribution, and archiving of submissions to health authorities.

Key Responsibilities:

  • Supervise external Submission Managers in defining submission outlines, content, format, and quality standards for electronic submissions, collaborating with Regulatory Affairs as necessary.
  • Ensure timely and accurate management of tracking, compiling, publishing, quality assurance, dispatching, and archiving of submissions to Health Authorities.
  • Facilitate submission preparation through the completion of necessary forms and the creation of cover letters.
  • Represent Regulatory Affairs Operations on project teams regarding electronic and paper submissions.
  • Oversee the accurate printing, distribution, and archiving of all communications with FDA and international regulatory agencies.
  • Lead the implementation and operation of electronic Common Technical Document (eCTD) and document management systems, along with other publishing technology initiatives.
  • Develop, refine, and implement internal processes, procedures, and training programs for submission production and operational support.
  • Stay updated on evolving Health Authority standards and guide project teams on new regulatory requirements.
  • Coordinate with other departments on the review and assembly of regulatory documentation.
  • Assist in creating regulatory project plans and timelines for multiple projects.
  • Train relevant R&D staff on various standards and technologies.

Core Competencies:

  • Detail-oriented self-starter with exceptional organizational and planning skills.
  • Able to manage competing deadlines and multiple priorities effectively.
  • Extensive knowledge of regulatory submission standards and procedures.
  • Thorough understanding of FDA and other health agency regulations governing submission content and format.

Education and Experience:

High School diploma required; Bachelor's degree preferred. A minimum of 8 years of relevant experience in the biotech or pharmaceutical sector is essential, with at least 7 years in a high-volume document production environment.

Compensation and Benefits:

The compensation package includes a competitive salary, merit-based increases, participation in incentive plans, eligibility for a 401(k) plan, and comprehensive health benefits including medical, dental, vision, life, and disability insurance, along with unlimited paid time off.

Compliance and Confidentiality:

All employees are expected to maintain compliance with applicable regulatory, legal, and operational rules. Confidentiality of all encountered information is paramount.

Equal Employment Opportunity:

Sumitomo Pharma America is committed to fostering a diverse workforce. All qualified applicants will receive consideration for employment without regard to any characteristic protected by law.

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