Lead Manager, Regulatory Affairs Operations

2 weeks ago

Jackson, Mississippi, United States Sumitomo Pharma Full time
Company Overview
Sumitomo Pharma Co., Ltd. is a prominent global pharmaceutical entity headquartered in Japan, with significant operations across the U.S., Canada, and Europe. Our focus lies in addressing critical patient needs across various therapeutic areas including oncology, urology, women's health, rare diseases, psychiatry & neurology, and innovative cell & gene therapies.

Position Summary
We are in search of a proactive and seasoned professional for the role of Lead Manager, Regulatory Affairs Operations. This position entails overseeing all regulatory activities related to the preparation, submission, and management of health authority documents for assigned projects.

Key Responsibilities
  • Supervise external Submission Managers in establishing submission outlines, content specifications, formatting, and quality standards for electronic submissions.
  • Ensure the precise and timely management of tracking, compiling, publishing, quality assurance, dispatching, and archiving of submissions to health authorities.
  • Facilitate the preparation of submissions by completing necessary forms and drafting cover letters.
  • Act as a representative of Regulatory Affairs Operations on project teams concerning electronic and paper submissions.
  • Oversee the management of all communications with health authorities, ensuring accurate printing, distribution, and archiving.
  • Lead the implementation and validation of electronic submission systems and document management technologies.
  • Develop, refine, and implement internal processes, procedures, and training programs to support submission production and operational activities.
  • Stay informed on evolving health authority standards and guide project teams on compliance with new requirements.
  • Coordinate with various departments to ensure comprehensive review and assembly of regulatory documentation.
  • Assist in the formulation of regulatory project plans and timelines for multiple initiatives.
  • Conduct training for relevant R&D personnel on standards and technologies related to document management and electronic submissions.

Core Competencies
We seek a detail-oriented self-starter with exceptional organizational, planning, and follow-up capabilities. The ideal candidate will have the ability to manage competing deadlines, prioritize multiple tasks, and possess extensive knowledge of regulatory submission standards and procedures. A thorough understanding of health agency regulations governing submission content and format is essential.

Qualifications
A minimum of 8 years of relevant experience in the biotech or pharmaceutical sector is required, with a preference for candidates holding a Bachelor's degree. Candidates with a Master's degree should have 6-8 years of experience. A background in a high-volume document production environment is advantageous.

Compensation and Benefits
The compensation for this role is competitive, with a base salary range reflective of experience and qualifications. Our comprehensive rewards package includes merit-based salary increases, participation in incentive plans, eligibility for retirement plans, and various insurance options along with paid time off.

Commitment to Diversity
Sumitomo Pharma America is an Equal Employment Opportunity and Affirmative Action employer, dedicated to fostering a diverse workforce. All qualified applicants will be considered for employment without regard to race, color, creed, religion, national origin, age, ancestry, nationality, marital status, sex, gender, gender identity or expression, disability, veteran status, or any other characteristic protected by law.

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