Associate Director, Global Regulatory Affairs - GI & Inflammation
TakedaPharmaceutical Nordics AB, Boston, Massachusetts, us, 02298
Associate Director, Global Regulatory Affairs – GI & Inflammation
Any additional information you require for this job can be found in the below text Make sure to read thoroughly, then apply. 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. xsgimln
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
Any additional information you require for this job can be found in the below text Make sure to read thoroughly, then apply. 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. xsgimln
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