Senior Associate, Regulatory Affairs – Promotional Operations

📋 Description

• Support the establishment of standards, planning, coordination, and processing of promotional materials.

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

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

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

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

• Ensure that all materials meet the established readiness criteria.

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

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

• Aid in the modification, development, and implementation of company practices and policies.

• Assist with regular regulatory compliance audits.

• Provide training to stakeholders on the PRC process.

⛳️ Requirements

• Bachelor’s degree (BA/BS) in a scientific or health-related field is preferred.

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

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

• Strong business acumen and effective decision-making skills.

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

• Excellent verbal and written communication abilities.

• Exceptional planning skills.

• Detail-oriented and self-motivated.

🏝️ Benefits

• Medical

• Dental

• Vision

• 401(k)

• FSA/HSA

• Life Insurance

• Paid Time Off

• Wellness

• Employee Stock Purchase Plan

• Discretionary Equity Awards