Remote Global Regulatory Strategy Senior Manager

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

Benefits offered by this job

Health benefits

401(k) match

Paid time off

Tuition reimbursement

Job summary

Otsuka America Pharmaceutical Inc. is seeking a regulatory affairs professional to support global regulatory strategy, planning, and execution of submissions for investigational and marketed prescription drugs.

You will manage lifecycle activities, assess regulatory challenges, and coordinate with the GRL and cross-functional teams to ensure timely, compliant submissions. The role requires experience with global submissions (IND/CTA/NDA/BLA/MAA), strong communication skills, and the ability to

Qualifications

• Bachelor's degree with 5+ years’ experience or Master’s with 2 years’ experience in regulatory affairs or related areas in pharma/healthcare.
• Experience with global regulatory submissions (IND, CTA, NDA/BLA, MAA) submissions.
• RAC certification a plus, knowledge of FDA/ICH regulations.

Responsibilities

• Develop global regulatory strategy and plans for orphan/regulated products.
• Coordinate submissions and responses to health authorities (INDs, CTAs, NDAs) within timelines.
• Provide regulatory guidance to cross-functional teams and GRL.
• Lead and coordinate internal/external resources for project deliverables.
• Ensure accuracy and compliance of submission documents and oversight of sponsor interactions with authorities.

Skills

Regulatory strategy

Regulatory intelligence

Leadership

Written communication

Office tools

EDMS

Education

Bachelor's degree in regulatory affairs/related field

Master's degree in regulatory affairs/related field

Tools

EDMS

Regulatory submissions software

MS Office

Job description

Otsuka America Pharmaceutical Inc. is seeking a regulatory affairs professional to support global regulatory strategy, planning, and execution of submissions for investigational and marketed prescription drugs.

You will manage lifecycle activities, assess regulatory challenges, and coordinate with the GRL and cross-functional teams to ensure timely, compliant submissions. The role requires experience with global submissions (IND/CTA/NDA/BLA/MAA), strong communication skills, and the ability to