Regulatory Affairs Operations Senior Leader

2 weeks ago

Hartford, Connecticut, United States Sumitomo Pharma Full time
Company Overview
Sumitomo Pharma is a prominent global pharmaceutical organization headquartered in Japan, with significant operations in North America and Europe. Our focus is on 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 experienced professional to fill the role of Senior Manager, Regulatory Operations. This position plays a pivotal role in overseeing all Regulatory Affairs activities related to the compilation, publishing, distribution, and archiving of submissions to health authorities.

Key Responsibilities
  • Lead external Submission Managers in establishing submission outlines, content, format, and quality standards for electronic submissions, ensuring alignment with Regulatory Affairs input.
  • Manage the external submission team to guarantee precise and timely 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 Operations on project teams concerning electronic and paper submissions.
  • Oversee the external team to ensure accurate printing, distribution, and archiving of all communications with regulatory agencies.
  • Lead the implementation and validation of electronic Common Technical Document (eCTD) and electronic document management systems, alongside other publishing and submission technology initiatives.
  • Develop, refine, and implement internal processes, procedures, and training programs for submission production and operational support.
  • Stay informed on evolving Health Authority standards and procedures for regulatory submissions.
  • Coordinate with various departments on the content, review, and assembly of regulatory documentation.
  • Assist in creating regulatory project plans and timelines for multiple initiatives.
  • Conduct training for relevant R&D personnel on various standards and technologies.

Core Competencies
The ideal candidate will possess a detail-oriented mindset, exceptional organizational and planning skills, and the ability to manage multiple priorities effectively. A comprehensive understanding of regulatory submission standards and procedures, as well as familiarity with FDA and other health agency regulations, is essential.

Qualifications
A Bachelor's degree is preferred, with a minimum of 8 years of relevant experience in the biotech or pharmaceutical industry, or 6-8 years with a Master's degree. Candidates should have at least 7 years of experience in a high-volume document production environment, ideally within the biotechnology or pharmaceutical sectors.

Compensation and Benefits
The salary range for this position is competitive and is complemented by a comprehensive benefits package, including opportunities for merit-based salary increases, participation in short incentive plans, and eligibility for our 401(k) plan, along with medical, dental, vision, life, and disability insurance.

Equal Employment Opportunity
Sumitomo Pharma is committed to fostering a diverse and inclusive workplace. We welcome applicants from all backgrounds and ensure equal opportunity in employment without regard to race, color, creed, religion, national origin, age, ancestry, nationality, marital status, sex, gender, gender identity or expression, affectional or sexual orientation, disability, veteran or military status, or any other characteristic protected by law.

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