Senior Associate, Regulatory Affairs – Promotional Operations

This is a fully remote position, open to applicants in United States.

📋 Description

• Assist in establishing standards, planning, coordinating, and processing promotional materials.

• Support the preparation of regulatory submissions for advertising and promotional content.

• Serve as a centralized knowledge resource for the Promotional Review Committee (PRC).

• Provide guidance on the submission process and review of materials.

• Manage review priorities in alignment with business needs and aid in material triage.

• Ensure materials are prepared in accordance with established criteria.

• Lead the process within the document management system (Veeva PromoMats).

• Collaborate with Global Regulatory Operations to ensure submissions comply with FDA requirements.

• Contribute to the modification, development, and execution of company practices and policies.

• Assist with regular regulatory compliance audits.

• Train stakeholders on the PRC process.

⛳️ Requirements

• BA/BS degree (preferably in a scientific or health-related field).

• At least 2+ years of direct experience in a Regulatory role or equivalent.

• General understanding of advertising and promotional regulations, guidelines, and best practices.

• Strong business acumen and decision-making skills.

• Demonstrated ability to achieve goals within a cross-functional team or partnership setting.

• Excellent oral and written communication abilities.

• Exceptional planning skills.

• Detail-oriented and proactive self-starter.

🏝️ Benefits

• Medical

• Dental

• Vision

• 401(k)

• FSA/HSA

• Life Insurance

• Paid Time Off

• Wellness

• Employee Stock Purchase Plan

• Discretionary Equity Awards