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Lead Manager, Regulatory Affairs Operations
2 months ago
Sumitomo Pharma is a leading global pharmaceutical organization headquartered in Japan, with significant operations across North America and Europe. We are dedicated to addressing critical patient needs in various therapeutic areas, including oncology, urology, women's health, rare diseases, psychiatry & neurology, and advanced therapies.
Position Summary
We are in search of a proactive and experienced professional for the role of Lead Manager, Regulatory Affairs Operations. This position is crucial for overseeing all regulatory activities related to the preparation, submission, and management of health authority documents.
Key Responsibilities
- Supervise external Submission Managers to establish submission frameworks, content specifications, formatting, and quality standards for electronic submissions.
- Ensure the timely and precise management of tracking, compiling, publishing, quality assurance, dispatching, and archiving of submissions to health authorities.
- Prepare and send OPDP submissions as required.
- Facilitate the submission process by completing necessary forms and drafting cover letters.
- Represent Regulatory Affairs Operations in project teams concerning electronic and paper submissions.
- Oversee the external Submission Managers to guarantee the accurate printing, distribution, and archiving of all communications with health authorities.
- Lead the implementation and operation of electronic submission systems and document management solutions.
- Develop, refine, and implement internal processes, procedures, and training programs to support submission production and operational activities.
- Stay informed about evolving health authority standards and submission procedures.
- Collaborate with various departments to ensure the accuracy and completeness of regulatory documentation.
- Assist in creating regulatory project timelines and plans for multiple projects.
- Train relevant R&D personnel on applicable standards and technologies.
Core Competencies
- Detail-oriented with strong organizational and planning abilities.
- Capable of managing multiple priorities and meeting tight deadlines.
- In-depth knowledge of regulatory submission standards and practices.
- Comprehensive understanding of regulations and guidelines from health agencies regarding submission content and format.
Qualifications
- High School diploma required; Bachelor's degree preferred.
- Minimum of 8 years of relevant experience in the biotech or pharmaceutical sector (6-8 years with a Master's degree).
- At least 7 years of experience in a high-volume document production environment, preferably within the biotechnology or pharmaceutical industry.
Compensation and Benefits
The compensation for this role is competitive, with a comprehensive benefits package that includes merit-based salary increases, participation in incentive plans, eligibility for retirement plans, and extensive insurance benefits. Our generous time-off policy offers unlimited paid time off along with additional perks.
Compliance and Confidentiality
All information encountered in this role is considered confidential. Compliance with all regulatory, legal, and operational standards is essential.
