Remote Global Regulatory Manager – IND/NDA Strategy

Otsuka America Pharmaceutical Inc.; Juneau (AK); Remote; USD 150,000 - 224,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

401(k) match

Paid time off

Tuition reimbursement

Student loan assistance

Job summary

Otsuka America Pharmaceutical Inc. seeks a Regulatory Affairs professional to develop and execute global regulatory strategies for investigational and marketed products. You will coordinate submissions, assess regulatory challenges, and work with the Global Regulatory Lead and cross-functional teams to ensure timely approvals.

The role requires strong knowledge of FDA/ICH guidelines, excellent communication, and the ability to manage multiple regulatory activities across product lifecycles.

Qualifications

• Experience in pharmaceutical regulatory submissions (IND, CTA, NDA/BLA) and life cycle management.
• Ability to translate global regulatory requirements and assess regulatory challenges.
• Experience interacting with health authorities and cross-functional teams.

Responsibilities

• Support development of global regulatory strategy and planning.
• Prepare and coordinate regulatory submissions and responses to authorities.
• Collaborate with GRL and global/regional teams to address regulatory issues.

Skills

Regulatory intelligence

Communication skills

Leadership

Regulatory strategy

FDA/ICH knowledge

Education

Bachelor's degree in regulatory affairs or related field

Master’s degree in regulatory affairs or related field

Tools

EDMS

Job description

Otsuka America Pharmaceutical Inc. seeks a Regulatory Affairs professional to develop and execute global regulatory strategies for investigational and marketed products. You will coordinate submissions, assess regulatory challenges, and work with the Global Regulatory Lead and cross-functional teams to ensure timely approvals.

The role requires strong knowledge of FDA/ICH guidelines, excellent communication, and the ability to manage multiple regulatory activities across product lifecycles.