Senior Research Associate GRA CMC

Takeda Pharmaceutical Company - Boston, MA

Full-time - Entry Level

Boston, MA

Chemical Manufacturing

About the position

The Sr Associate, Global Regulatory Affairs CMC Submission Management at Takeda plays a crucial role in supporting the execution of regulatory CMC tasks for investigational, registration, and post-approval activities. This position involves collaboration with cross-functional teams to develop project plans for global regulatory submissions, ensuring compliance with regulatory strategies and timelines. The role requires organization and management of CMC-related documents, contributing to regulatory compliance, and engaging in continuous improvement initiatives.

Responsibilities

• Support in executing and managing regulatory tasks for assigned projects (IND/ IMPD/ CTA/ MAA) according to the regulatory strategy.
• Collaborate with cross-functional teams to develop project plans for global regulatory submissions and ensure alignment with business objectives and timelines.
• Provide guidance to global project teams on submission processes, workflows, tools/systems, and filing strategy.
• Participate in the creation of submission content plans for assigned projects and monitor progress.
• Plan, manage, and track delivery of submission components, coordinate submission publishing activities, and organize submission review and approvals.
• Define CMC content requirements for regulatory submissions and review this content for conformance with established requirements.
• Ensure and/or enhance regulatory compliance as a RA CMC member.
• Inform project team colleagues and stakeholders of developments that may impact regulatory success.
• Work effectively with cross-functional teams to contribute to broader organizational goals and initiatives.
• Collaborate with AI specialists to develop and implement AI-based solutions for regulatory challenges.
• Contribute to CMC preparation activities for meetings with Health Authorities on CMC-related matters.

Requirements

• BS Degree in a science discipline; advanced degree preferred.
• 1-2 years of regulatory and/or related experience preferred.
• Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support.
• Strong oral and written communication skills with individuals at all levels of the organization.
• Ability to prioritize while managing multiple projects of varied complexity and criticality.
• Demonstrates problem-solving ability with the ability to analyze risk and provide appropriate recommendations.
• Strong interpersonal skills combined with cultural sensitivity for successful global collaboration.
• Focus on accuracy and strong attention to detail.
• Willingness to provide and receive constructive feedback.
• Project management skills to oversee and coordinate various CMC activities.
• Self-motivated with the ability to work independently and in a team.

Nice-to-haves

• Pharmaceutical industry experience preferred.
• Basic knowledge of publishing tools such as CTDxpress, Docubridge; Veeva RIM; global submission validation tools; Document Management systems.

Benefits

• Medical, dental, and vision insurance
• 401(k) plan with company match
• Short-term and long-term disability coverage
• Basic life insurance
• Tuition reimbursement program
• Paid volunteer time off
• Company holidays
• Well-being benefits
• Up to 80 hours of sick time per calendar year
• Up to 120 hours of paid vacation for new hires