Regulatory Specialist - São Paulo, Brazil

Baxter; São Paulo; Presencial; BRL 80.000 - 120.000; Tempo integral

Resumo da oferta

A global healthcare company in São Paulo is seeking a Regulatory Affairs professional to implement complex global regulatory strategies. Your role will include managing the local regulatory processes, providing advice, and ensuring compliance for medical devices. The ideal candidate has a Bachelor's in Pharmacy and fluent English, coupled with strong negotiation and project management skills. This position will allow you to make a significant impact on healthcare and compliance globally.

Qualificações

• Fluent English is mandatory, Spanish at least intermediate.
• Knowledge of local regulations.
• Ability to multitask and prioritize.
• Ability to identify compliance risks and escalate when necessary.

Responsabilidades

• Responsible for local implementation of global regulatory strategies.
• Initiate and develop complex regulatory project plans.
• Provide regulatory advice to project teams.
• Compile and submit regulatory documents according to requirements.
• Prepare, review, and approve labeling for compliance.

Conhecimentos

Fluent English

Strong negotiation skills

Project management skills

Interpersonal and communication skills

Technical system skills

Formação académica

Bachelor's degree in Pharmacy or equivalent

Descrição da oferta de emprego

This is where you save and sustain lives

About Baxter

At Baxter, we are deeply connected by our mission.

No matter your role at Baxter, your work makes a positive impact on people around the world.

You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home.

For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other.

This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

Your role at Baxter

Responsible for the local implementation of complex global regulatory strategies, obtain and maintain marketing authorizations for product(s) and communication of local regulatory requirements in support of licensing of medical devices products.

Serves as a consultant to managers.

Manage regulatory activities relating to specific portfolio of products / projects.

What you'll be doing

• Initiate and develop complex regulatory project plans
• Identify & prioritize key areas of regulatory risk
• Monitor applicable regulatory requirements
• Create and maintain regulatory files in a format consistent with requirements
• Provide regulatory advice to project teams.
• Respond to complex questions from regulatory authorities within strict timelines
• Compile and submit, in a timely manner, regulatory documents according to regulatory requirements
• Maintain and update existing regulatory authorizations
• Manage regulatory activities relating to specific portfolio of products / projects
• Prepare, review, and approve labeling and review AdProm materials for compliance with local regulations
• Prepare SOPs to reflect specific local requirements.
• Lead or represent Regulatory Affairs in project teams
• Provide guidance and coaching for areas of responsibility to lower level team member

What you'll bring

• Bachelor's degree in a Pharmacy or equivalent
• Fluent English is mandatory, Spanish, at least intermediate
• Knowledge of local regulations
• Project management skills
• Manage multiple projects and deadlines
• Ability to multitask and prioritize
• Interpersonal and communication skills
• Strong negotiation skills
• Technical system skills (e.g. word processing, spreadsheets, databases, online research)
• Ability to work effectively in multinational / multicultural environment
• Ability to identify compliance risks and escalate when necessary

Reasonable Accommodations

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