Associate Director, Global Regulatory Affairs - 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

Associate Director, Global Regulatory Affairs – GI & Inflammation

Apply for the role at TakedaPharmaceutical Nordics AB.

Job Description

Associate Director responsible for regulatory affairs for GI & Inflammation programs. Provides strategic and tactical advice, leads cross‑functional initiatives, and maintains compliance with regulatory requirements.

Accountabilities

• Lead global regulatory strategies for complex or highly complex projects.
• Define and execute global regulatory strategies and provide tactical guidance.
• Represent Global Regulatory Teams at project meetings and maintain regulatory compliance.
• Establish and manage relationships with health authorities, including FDA meetings.
• Accountable for all US FDA submissions related to assigned projects.
• Oversee vendor responsibility for regulatory activities.
• Partner with market access for value evidence topics.
• Demonstrate Takeda leadership behaviors.

Education & Competencies

• Bachelor’s Degree in a scientific discipline (PharmD/PhD/MD strongly preferred).
• 6+ years of pharmaceutical industry experience, including 4+ years regulatory experience.
• Preferred experience in reviewing, authoring, or managing components of regulatory submissions.
• Solid knowledge of drug development process and regulatory requirements (FDA, EU, Canada, ROW).
• Strong oral and written communication skills and negotiation ability.
• Proactive risk‑mitigation and strategic regulatory solution development.
• Team collaboration and global team alignment.

Hybrid Statement

This position is classified as “hybrid” in accordance with Takeda’s Hybrid and Remote Work policy.

Compensation and Benefits Summary

Location: Boston, MA

Base Salary Range: $153,600.00 – $241,340.00

U.S. based employees may be eligible for short‑term and long‑term incentives. Benefits include medical, dental, vision, 401(k) with match, short‑term and long‑term disability, life insurance, tuition reimbursement, volunteer time off, company holidays, and well‑being benefits. Paid vacation up to 120 hours and sick time up to 80 hours per year.

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information, marital status, veteran status, or other protected characteristic.

Job Details

Job Exempt: Yes

Job Function: Legal

Industry: Pharmaceutical Manufacturing

Worker Type: Employee

Time Type: Full time

Seniority Level: Director

Employment Type: Full‑time