Global Regulatory Strategy Lead - GI & Inflammation

Takeda; Cambridge (MA); On-site; USD 175,000 - 200,000; Full time

Job summary

A leading pharmaceutical company in Cambridge is seeking a Senior Director, Global Regulatory Lead for GI & Inflammation. This role is critical in ensuring compliance and securing regulatory approvals for new products. The ideal candidate will have over 12 years of experience in the pharmaceutical industry with a strong background in regulatory affairs. You will lead multiple teams and oversee all FDA submissions, driving strategic regulatory initiatives aligned with business goals. The role offers an executive-level position with competitive compensation.

Qualifications

• 12+ years of pharmaceutical industry experience including 10 years in regulatory.
• Experience in reviewing or managing components of regulatory submissions.
• Knowledge of FDA, EU, Canada, ROW and post-marketing requirements.

Responsibilities

• Lead multiple projects and Global Regulatory Teams (GRTs).
• Ensure compliance with legislative and regulatory changes.
• Accountable for all US FDA submissions.

Skills

Expert in preparing and managing regulatory submissions

Skilled in analyzing complex data sets

Proficient in leading project teams

Experienced in interacting with government authorities

Capable of high-stakes negotiations

Able to mentor junior staff

Strong strategic planner

Excellent communication skills

Education

Bachelor’s Degree in scientific discipline

Advanced degree (PharmD/PhD/MD)

Job description

A leading pharmaceutical company in Cambridge is seeking a Senior Director, Global Regulatory Lead for GI & Inflammation. This role is critical in ensuring compliance and securing regulatory approvals for new products. The ideal candidate will have over 12 years of experience in the pharmaceutical industry with a strong background in regulatory affairs. You will lead multiple teams and oversee all FDA submissions, driving strategic regulatory initiatives aligned with business goals. The role offers an executive-level position with competitive compensation.