Senior Associate, Regulatory Affairs – Promotional Operations

🕒 May 6

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BeOne Medicines

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10,000+ employees

Founded 2010

BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. With a growing global team of more than 11,000 colleagues spanning six continents, the Company is committed to radically improving access to medicines for far more patients who need them.

📋 Description

• Assist in driving standards, planning, coordination, and processing of promotional materials • Support preparation of regulatory submissions for advertising and promotional materials • Act as a centralized knowledge hub of Promotional Review Committee (PRC) • Provide guidance on the submission process and materials review • Manage review priorities against business needs and assist in material triage • Ensure readiness of materials according to established criteria • Drive the process within the document management system (Veeva PromoMats) • Collaborate with Global Regulatory Operations for submissions in accordance with FDA requirements • Contribute to modification, development, and implementation of company practices and policies • Assist with periodic regulatory compliance audits • Train stakeholders on PRC process

🎯 Requirements

• BA/BS degree (preferably in a scientific or health-related discipline) • Minimum of 2+ years of direct experience in a Regulatory function or equivalent • General knowledge of advertising/promotional regulations, guidelines, and best practices • Strong business acumen and decision-making ability • Proven ability to deliver on goals within a cross-functional team/partnership environment • Excellent oral and written communication skills • Superior planning skills • Detail-oriented and self-starter

🏖️ Benefits

• Medical • Dental • Vision • 401(k) • FSA/HSA • Life Insurance • Paid Time Off • Wellness • Employee Stock Purchase Plan • Discretionary Equity Awards