Senior Manager, Global Regulatory Affairs (Pharmaceutical)

Location: Remote within the United States; approximately 20% travel required.

Salary: $150,034–$224,250 per year, plus incentive opportunity.

Company

Otsuka Pharmaceutical develops and commercializes pharmaceutical and healthcare products.

What you will do

• Support global regulatory strategy, planning, execution, and lifecycle management for investigational and marketed prescription drug programs.
• Research regulatory intelligence, precedent approvals, and health authority decisions to develop strategic options.
• Develop global regulatory plans and address regulatory issues, authority queries, and regulatory obligations with cross-functional teams.
• Author, coordinate, review, and execute IND, CTA, NDA, BLA, MAA, amendment, supplement, and aggregate report submissions.
• Serve as the sponsor point of contact for health authorities and provide regulatory guidance to project teams.
• Direct internal support staff and external consultants while managing timelines, risks, documentation quality, and departmental improvement initiatives.

Requirements

• Bachelor's degree with 5+ years of experience, or a master's degree with 2 years of experience, in regulatory affairs or a related pharmaceutical or healthcare field.
• Experience preparing global regulatory submissions, including INDs, CTAs, NDAs or BLAs, and MAAs.
• Working knowledge of the drug development process, applicable laws, regulations, FDA requirements, and ICH guidelines.
• Ability to interpret regulatory intelligence, lead teams, manage priorities, and communicate project progress and risks.
• Strong written and oral communication, organizational, collaboration, and problem-solving skills.
• Experience with Microsoft Office and familiarity with electronic document management systems.

Nice to have

• Regulatory Affairs Certification (RAC).
• Experience interacting with the FDA or other health authorities.

Culture & Benefits

• Remote work arrangement with flexible time off, paid holidays, and paid leave programs.
• Medical, dental, vision, and prescription drug coverage.
• Company-provided life, accidental death and dismemberment, short-term disability, and long-term disability insurance.
• Tuition reimbursement and student loan assistance.
• Generous 401(k) matching and additional company-provided benefits.