Home Jobs Nonclinical Regulatory Writing and Submission Support, Sr. Manager
Back to Jobs

Nonclinical Regulatory Writing and Submission Support, Sr. Manager - Job Opportunity at Takeda Pharmaceutical

Boston, USA
Full-time
Senior
Posted: February 2, 2025
Remote
USD 133,000 - 209,000 per year

Benefits

Competitive 401(k) matching program aligned with industry standards
Comprehensive health insurance package including medical, dental, and vision
Enhanced disability and life insurance coverage
Liberal paid time off policy with additional paid holidays
Tuition reimbursement for continued education
Wellness programs and work-life balance initiatives

Key Responsibilities

Lead strategic development and execution of nonclinical regulatory documentation across multiple therapeutic areas
Drive innovation in regulatory writing processes through AI/GenAI integration and automation
Manage cross-functional teams for regulatory submission preparation and coordination
Oversee quality control and compliance with global regulatory requirements
Direct document lifecycle management and submission strategies

Requirements

Education

Ph.D. or M.Sc. in scientific field (biology, pharmacology, toxicology)

Experience

8 years minimum in nonclinical regulatory writing

Required Skills

Advanced knowledge of ICH guidelines and regulatory requirements Expertise in drug development across multiple modalities Program management capabilities Digital dexterity Strong communication and influencing skills Problem-solving abilities Global ecosystem experience

Certifications

Regulatory Affairs Credential (RAC-Drugs) preferred
Advertisement
Ad Space

Sauge AI Market Intelligence

Industry Trends

Increasing focus on AI and automation in regulatory documentation processes is reshaping traditional writing roles Growing complexity in regulatory requirements across global markets is driving demand for specialized expertise Shift towards innovative therapeutic modalities requiring broader technical knowledge

Salary Evaluation

The offered range is competitive for the Boston market, particularly given the senior level and specialized nature of the role. Top performers with extensive experience could command up to USD 225,000 annually.

Role Significance

Typically leads a team of 3-5 regulatory writers while coordinating with 15-20 cross-functional stakeholders
Senior strategic position with significant influence on regulatory submission success and process innovation

Key Projects

First-in-Human (FIH) regulatory submissions Major market authorization applications Process automation and efficiency initiatives Cross-functional regulatory strategy development

Success Factors

Deep understanding of global regulatory landscapes and ability to navigate complex requirements Strong project management skills with ability to handle multiple high-priority submissions Advanced technical writing capabilities combined with scientific expertise Innovation mindset for process improvement and automation adoption

Market Demand

High demand with growing trajectory due to increasing regulatory complexity and expansion of biopharmaceutical development programs

Important Skills

Critical Skills

Regulatory writing expertise with focus on nonclinical documentation Cross-functional leadership and stakeholder management Technical proficiency in drug development processes

Beneficial Skills

AI/automation technology understanding Experience with multiple therapeutic modalities Global regulatory strategy expertise

Unique Aspects

Emphasis on AI/GenAI integration in regulatory writing processes
Focus on First in Human (FIH) programs across multiple therapeutic areas
Strong support for process innovation and automation

Career Growth

2-4 years in role before advancement, depending on performance and organizational growth

Potential Next Roles

Director of Regulatory Affairs Head of Regulatory Operations Global Regulatory Strategy Leader

Company Overview

Takeda Pharmaceutical

Takeda is a global biopharmaceutical leader with strong focus on R&D and innovation in specialized therapeutic areas

Top 15 global pharmaceutical company with significant market presence and robust pipeline
Major presence in Boston biotech hub with significant R&D operations
Innovation-focused environment with emphasis on work-life balance and professional development
Advertisement
Ad Space
Apply Now

Data Sources & Analysis Information

Job Listings Data

The job listings displayed on this platform are sourced through BrightData's comprehensive API, ensuring up-to-date and accurate job market information.

Sauge AI Market Intelligence

Our advanced AI system analyzes each job listing to provide valuable insights including:

  • Industry trends and market dynamics
  • Salary estimates and market demand analysis
  • Role significance and career growth potential
  • Critical success factors and key skills
  • Unique aspects of each position

This integration of reliable job data with AI-powered analysis helps provide you with comprehensive insights for making informed career decisions.