Director Site CMC - Remote

Overview

The Director Site CMC at Takeda is responsible for managing regulatory change control and post-approval activities at the site level, focusing on innovation and compliance in the biopharmaceutical industry.

In Short

• Lead site-specific post-approval change management activities.
• Drive standardization and sustainability in regulatory processes.
• Explore automation to enhance efficiency in submissions.
• Collaborate with external manufacturing sites and partners.
• Evaluate changes based on risk and scientific rationale.
• Facilitate alignment with global Regulatory CMC.
• Implement streamlined workflows for regulatory change control.
• Promote sustainable practices in regulatory operations.
• Foster an inclusive culture within the team.
• Communicate regulatory strategy effectively across teams.

Requirements

• BS/BA Degree in a Scientific Discipline; advanced degree preferred.
• 10+ years in biopharmaceutical/device industry.
• 8+ years in pharmaceutical Regulatory CMC or Device experience.
• Strong understanding of global HA requirements.
• Excellent analytical and problem-solving skills.
• Ability to develop global regulatory strategy recommendations.
• Strong leadership and collaboration skills.
• Excellent written and oral communication skills.
• Experience with ICH Q12 principles.
• Proven ability to manage critical issues with minimal oversight.

Benefits

• Equitable pay and transparent pay practices.
• Short-term and long-term incentives for U.S. employees.
• Medical, dental, and vision insurance.
• 401(k) plan with company match.
• Tuition reimbursement program.
• Paid volunteer time off and company holidays.
• Up to 120 hours of paid vacation for new hires.
• 80 hours of sick time per calendar year.
• Commitment to diversity and equal employment opportunities.
• Flexible work arrangements including hybrid options.