Senior Manager, Regulatory Affairs, Advertising and Promotion Job at BeOne Medic

General Description :

The Manager, Regulatory Advertising and Promotion will be responsible for the review and approval of promotional materials for assigned marketed products in coordination with key internal stakeholders. This person will also provide strategic support for 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.

This role provides regulatory support, oversight, and strategic guidance on promotional and non-promotional communications or activities for BeOne's marketed products in North America. This role supports our commercial, medical affairs, legal, healthcare compliance and other business functions in the United States and Canada to ensure compliance with applicable regulatory requirements and guidelines, and consistency with approved labeling.

Essential Functions of the Job :

Performs regulatory review for promotional materials in conformance with local regulatory requirements and company policies / standards.

May also perform regulatory review for non-promotional medical, HEOR, and corporate / investor materials.

Supports preparation of regulatory submissions for advertising and promotional materials.

Provides strategic and operational regulatory direction on requirements for promotional and non-promotional materials and associated risk assessments.

Establishes and maintains effective cross functional working relationship with internal and external stakeholders.

Liaises and negotiates with regulatory authorities as needed for all aspects pertaining to promotional activities including resolution of key regulatory issues.

Prepares and updates Regulatory Standard Operating Procedures and Working Instructions, and provides regulatory review of procedures, as necessary.

Maintains up to date information regarding initiatives by FDA, Health Canada, and other applicable regulatory authorities related to advertising / promotion.

Integrates functional expertise with business knowledge to solve problems and make good decisions for the overall business.

Adheres to Company's policies and supports management decisions and goals.

Skills and Experience :

Minimum of two years of experience in a Regulatory ad / promo directly reviewing promotional materials. Product launch experience preferred.

Experience with Veeva PromoMats preferred.

General knowledge of advertising / promotional regulations, guidelines and best practices

Prior experience with new product launches and Subpart H / E products highly desired.

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.

Supervisory Responsibilities :

• None, initially. May hire and manage direct reports in the future.

Computer Skills : Proficiency in MS Office Suite applications. Adobe Acrobat and Veeva Vault systems experience preferred.

Education / Experience Required :

Bachelor's degree (BS / BSc or BA), preferably in a scientific or health-related discipline, 5 years of experience in the biotechnical or pharmaceutical industry, and a minimum of 2 years' experience in a Regulatory capacity with a relevant background. Prior experience reviewing promotional materials is required.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.