Manager, Global Regulatory Affairs - Advertising & Promotion

Aquí es donde salvas y sostienes vidas

En Baxter, estamos profundamente conectados por nuestra misión. No importa tu rol en Baxter, tu trabajo tiene un impacto positivo en la gente alrededor del mundo. Sentirá un propósito en toda la organización, ya que sabemos que nuestro trabajo mejora los resultados para millones de pacientes.

Los productos y terapias de Baxter se encuentran en casi cada hospital del mundo, el clínicas y en los hogares. Por más de 85 años hemos sido pioneros en innovaciones médicas significativas que transforman el cuidado en salud.

Juntos creamos un lugar donde somos felices, exitosos y nos inspiramos mutuamente. Aquí es donde puedes hacer tu mejor trabajo.

Únete a nosotros en la intersección de salvar y sostener vidas-donde tu propósito acelera nuestra misión.

Your Role at Baxter
The Manager of Regulatory Affairs-Advertising/Promotion reports to the Sr Director Regulatory Affairs and is responsible for the review of Advertising and Promotional (Ad Prom) materials and accountable for all operational aspects of regulatory submissions providing planning and technical support for Baxter’s products for one or more business units/countries.

What You'll Be Doing

• Review and approve advertising and promotional materials such as Medical Devices

• Initiate, manage and maintain operational activities in support of new and existing marketing authorizations

• Plan and manage complex projects and prioritize workload

• Monitor, evaluate, and interpret all applicable regulatory requirements, assure compliance with Baxter and external standards

• Maintain appropriate communication within the RA function, BU marketing, and other functions primarily at the project team level

• Communicate proactively and report to regulatory authorities

• Evaluate technical and scientific information, identify deficiencies, implement and execute strategies to remediate risks

• Assess impact of new regulations and provide feedback.

• Set team, group, or service objectives to assure they align with the Regulatory strategy

• Provide technical and strategic input for regulatory decisions

• Support Regulatory Affairs team's ownership of the global Ad Prom process and system

• May provide direct supervision of individuals including mentoring, performance management and staffing decisions.

What You'll Bring

• Minimum of 6 years of experience in Regulatory Affairs or Advertising & Promotion, preferably managing people or projects.

• Significant Regulatory knowledge in the Ad Prom (MLR) space and/or other Regulatory functions

• Scientific knowledge

• Strong ability to work with cross-functional teams

• Strong ability to oversee multiple projects in a matrix team environment.

• Demonstrated excellent interpersonal and collaboration skills, including diplomacy to negotiate conflicting priorities.

• Excellent oral and written communication and presentation skills.

• Ability to accomplish results through others

• Ability to lead, coach, and motivate others

• Bachelor’s degree or country equivalent in related scientific discipline

• Experience with Veeva Promomats is a plus.

Baxter is committed to supporting the needs for flexibility in the workplace. We do so through our flexible workplace policy which includes a required minimum number of days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission. The flexible workplace policy is subject to local laws and legal requirements. At its discretion, Baxter may decide to adjust, suspend, or discontinue as business needs change.

We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $112,000 - $154,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to ch