Senior Regulatory Affairs Specialist (JBP2026)

Job Description

Job Description

Description:

We are seeking an experienced Senior Regulatory Affairs Specialist to support the implementation of emerging global regulatory requirements across multiple franchises and international markets. This role is responsible for assessing regulatory changes, coordinating impact assessments, driving implementation activities, and ensuring regulatory requirements are effectively integrated into quality systems, processes, and business operations. 

Key Responsibilities
Emerging Regulatory Issues Implementation

Lead pan-franchise implementation of emerging global regulatory requirements across international markets.

Assess new or changing international regulations to determine business impact, implementation needs, risks, and timelines.

Coordinate cross-functional gap assessments and implementation plans to ensure regulatory requirements are incorporated into quality systems, procedures, labeling processes, and business operations to support continued market access and compliance.

Partner with Regulatory Affairs, Quality, Labeling, Supply Chain, Legal, and affiliate teams to drive timely and compliant execution.

Monitor implementation activities, identify risks, and drive issue resolution to support on-time compliance.

Compliance Governance & Audit Readiness

Support audit readiness activities across Regulatory Affairs functions by identifying compliance risks, quality system gaps, and remediation opportunities.

Track audit observations, remediation activities, and compliance commitments through completion.

Develop and maintain KPIs, dashboards, trackers, and governance reports to provide visibility into implementation progress, compliance risks, and key deliverables.

Support regulatory audit readiness activities and participate in internal, external, and regulatory inspections as needed.

Cross-Functional Leadership

Act as a key liaison between Regulatory Affairs, Quality, Regulatory Compliance, Labeling, and international affiliates to resolve complex regulatory challenges

Facilitate cross-functional governance meetings and drive decision-making and accountability

Influence stakeholders and align priorities across multiple functions and geographies

Communicate implementation plans, risks, and progress updates to stakeholders and leadership.

May serve as an interim lead for the Emerging Issues SME team, supporting prioritization, coordination, and execution of key activities.

Regulatory Operations & Documentation

Lead change management activities associated with regulatory and procedural updates.

Manage change order activities required to support regulatory and quality system updates.

Support management of post-approval regulatory commitments and associated deliverables.

Identify and implement process improvements to enhance efficiency, visibility, and compliance within regulatory operations.

Maintain and enhance KPI dashboards / Management Review Metrics to ensure health of Product Approval Key Process