BeOne Medicines is hiring : Senior Manager, Regulatory Affairs, Advertising and P

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.

In Summary : The Manager, Regulatory Advertising and Promotion will be responsible for the review and approval of promotional materials for assigned marketed products . 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 .

En Español : Descripción general : El Gerente de Publicidad y Promoción Reguladora será responsable de la revisión y aprobación de los materiales promocionales para productos comercializados asignados en BeOne, en coordinación con las partes interesadas internas clave. Esta persona también proporcionará apoyo estratégico a la preparación de presentaciones reguladoras para materiales publicitarios y promocionales. Se requiere una comunicación fuerte (escrita y verbal) y habilidades organizativas con una actitud colaborativa, práctica y "can-do". Establece y mantiene una relación de trabajo interfuncional efectiva con las partes interesadas internas y externas. Enlaza y negocia con las autoridades reguladoras según sea necesario para todos los aspectos relacionados con actividades promocionales, incluida la resolución de cuestiones regulatorias clave. Prepara y actualiza Procedimientos Operativos Normativos Reguladores e Instrucciones de Trabajo, y proporciona revisión reglamentaria de procedimientos, si es necesario. Mantiene información actualizada sobre iniciativas de la FDA, Health Canada y otras autoridades regulatorias aplicables relacionadas con la publicidad / promoción. Integra conocimiento funcional con el conocimiento empresarial para resolver problemas y tomar buenas decisiones para el negocio en general. Se adhiere a las políticas de la Compañía y apoya las decisiones y objetivos de gestión. Competencias y experiencia : Un mínimo de dos años de experiencia en un nivel directo de promoción / promoción de materiales promocionarios. Experiencia del producto preferido. El candidato debe estar orientado a los detalles, ser un auto-iniciador y sentirse cómodo con amplias responsabilidades en un entorno emprendedor y acelerado. Responsabilidades de supervisión : Ninguna, inicialmente. Puede contratar y administrar informes directos en el futuro. Competencias informáticas : Proficiencia en las aplicaciones MS Office Suite. Se prefiere experiencia en sistemas Adobe Acrobat y Veeva Vault. Educación / Experiencia Requerida : Licenciatura (BS / BSc o BA), preferiblemente en una disciplina científica o relacionada con la salud, 5 años de experiencia en la industria biotecnológica o farmacéutica, y un mínimo de 2 años en una experiencia con antecedentes relevantes.