Senior Associate, Regulatory Affairs, Promotional Operations

BeiGene

About The Position

The Senior Associate, Regulatory Promotional Operations, is responsible for assisting with driving standards, planning, coordination and processing of promotional materials. This person will also support the preparation of regulatory submissions for advertising and promotional materials. Strong communication (written and verbal), and organizational skills are required with a collaborative, hands-on, can-do attitude.

Requirements

BA/BS degree (BS/BSc or BA), (preferably in a scientific or health-related discipline) with a 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 ability to make sound decisions that contribute positively to the business.
Proven ability to deliver on goals within a cross-functional team/partnership environment with a high level of professionalism.
Excellent oral and written communication skills are a must, as are superior planning skills.
The candidate should be detailed-oriented, a self-starter, and be comfortable with broad responsibilities in an entrepreneurial, fast-paced environment.
Experience using electronic content management systems.
Proficiency in MS Office Suite applications.
Adobe Acrobat.

Nice To Haves

Direct experience with Veeva PromoMats and RIM is highly desirable.

Responsibilities

Assists in acting as a centralized knowledge hub of Promotional Review Committee (PRC) and provides guidance to project owners/agencies/reviewers on the process to streamline material review.
Collaborates with brand to set prioritization of review and manage review priorities against business needs.
Assists in triage of materials for appropriate review and provides guidance on submission readiness.
Reviews materials to ensure readiness according to established criteria and templates as applicable (e.g. proper referencing and annotations).
Drives the process within the document management system (Veeva PromoMats) for review and management of promotional materials.
Works in partnership with Global Regulatory Operations to prepare Subpart H and 2253 submissions in accordance with FDA requirements and timelines.
Contributes to the modification, development and implementation of company practices and policies for advertising and promotional activities.
Establishes and maintains effective working relationships with cross-functional partners.
Assists with periodic regulatory compliance audits to ensure effective proactive adherence to required government and corporate standards.
Assists in training stakeholders on PRC process.
Other tasks and responsibilities as assigned.