Regulatory Affairs & Compliance Senior I

Primary Purpose
Develops regulatory positions, drafts complex filings, and leads cross-functional coordination for compliance initiatives. Strengthens strategic outcomes by ensuring submissions meet regulatory standards and advance organizational interests.

Duties and Responsibilities

• Develops positions and drafts complex filings (new registrations, significant variations, rate cases with customer impact models); structures arguments and evidence for approval.
• Coordinates cross‑functional evidence packages (quality systems, testing, safety, customer impact) and aligns timelines to regulator milestones.
• Advises on compliance for growth initiatives (new product lines, acquisitions, market entries); outlines regulatory pathways, risks, and mitigations.
• Leads root‑cause reviews after audit or inspection findings; designs corrective and preventive actions that address system causes.
• Represents the organization in technical committees or industry forums; explains compliance rationale and proposed policy outcomes.
• Crafts well‑supported responses to deficiency letters or data requests; negotiates realistic timelines and commitments.
• Leads small improvement projects (submission quality improvements, labeling claim libraries, change‑control enhancements) with measurable outcomes.
• Mentors junior staff on drafting techniques, regulator engagement, and evidence building.
• Performs other duties as assigned.