Global Regulatory Director – GI & Inflammation

TakedaPharmaceutical Nordics AB; Boston (MA); Hybrid; USD 153,600 - 241,340; Full time

Benefits offered by this job

Medical, dental, vision insurance

401(k) with match

Paid vacation and sick time

Tuition reimbursement

Well-being benefits

Job summary

A leading pharmaceutical company is seeking an Associate Director, Global Regulatory Affairs for GI & Inflammation programs in Boston, MA. This role involves leading regulatory strategies, maintaining compliance, and coordinating with health authorities. The ideal candidate will hold a scientific degree, possess extensive experience in regulatory affairs, and demonstrate strong negotiation and communication skills. The position offers a hybrid work model and a competitive salary ranging from $153,600 to $241,340, along with comprehensive benefits.

Qualifications

• Bachelor’s Degree in a scientific discipline, preferably PharmD/PhD/MD.
• 6+ years of pharmaceutical industry experience, including 4+ years in regulatory affairs.
• Experience in reviewing and managing regulatory submissions.

Responsibilities

• Lead global regulatory strategies for complex projects.
• Define and execute regulatory strategies and provide tactical guidance.
• Establish and manage relationships with health authorities.

Skills

Strong oral and written communication skills

Negotiation ability

Team collaboration

Proactive risk-mitigation

Strategic regulatory solution development

Education

Bachelor’s Degree in a scientific discipline

PharmD/PhD/MD strongly preferred

6+ years of pharmaceutical industry experience

4+ years of regulatory experience

Job description

A leading pharmaceutical company is seeking an Associate Director, Global Regulatory Affairs for GI & Inflammation programs in Boston, MA. This role involves leading regulatory strategies, maintaining compliance, and coordinating with health authorities. The ideal candidate will hold a scientific degree, possess extensive experience in regulatory affairs, and demonstrate strong negotiation and communication skills. The position offers a hybrid work model and a competitive salary ranging from $153,600 to $241,340, along with comprehensive benefits.