Senior Specialist, Labeling & Regulatory Affairs

Senior Specialist, Labeling & Regulatory Affairs
High-level Description
Contribute to developing valuable new drugs and business continuity by providing and implementing optimal labeling and regulatory strategy in order to achieve BMS business targets.

Have deep knowledge of up-to-date labeling information and finalize labeling through appropriate strategy at all development stages, preparing applications and handling approval reviews.

Provide support (CPP, etc.) for global applications, leveraging Japan approvals for global use.

Submit post‑marketing applications, notifications (approval without clinical/CMC data, transfer of approvals, withdrawals) and labeling updates for all products.

Conduct regulatory checks on product packaging materials.

Offer suggestions on promotional materials and communication of labeling with regulatory authorities.

Development Stage

Prepare target labeling drafts using protocols and competitor labeling.

Obtain stakeholder agreement on target labeling in cooperation with the Regulatory Strategy Lead.

Approval Application / Review Stage

Contribute to the optimal labeling strategy.

Prepare the best labeling draft after assessing current information, risks, and sharing with stakeholders.

Obtain stakeholder agreement on final draft labeling from Development, Global, Marketing, or Senior management.

Analyze acceptance scenarios and enhance predictability by providing options.

Support for Global Applications

Obtain global agreement on the support needed for the regulatory strategy.

Prepare and submit necessary documents for CPP, etc., and coordinate procedures with regulatory authorities and embassies.

Maintenance of Marketed Products

Submit post‑marketing applications and notifications.

Develop application documents for applications without clinical/CMC data.

Cooperate with global teams for timely approval responses.

Collaborate with Global Labeling team to revise labeling and ensure compliance.

Lead labeling strategy with cross‑functional teams.

Required Knowledge / Skills

Specialized scientific knowledge and R&D process familiarity.

Up‑to‑date regulatory knowledge and experience in regulatory work.

Understanding of local and global labeling and mature product roles.

Communication and teamwork skills.

Results orientation and strategic negotiation skills.

Problem‑solving and analytical thinking.

Ability to adapt to environmental change.

Strong English communication (audio conference, email).

Legal Statements
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Any data processed in connection with role applications will be treated according to applicable data privacy policies and regulations.

BMS will consider for employment qualified applicants with arrest and conviction records as per applicable laws.

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