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Regulatory Affairs Manager

3 semanas atrás

Sao Paulo, Brasil BD Tempo inteiro

We're searching for a professional that will help us to build a strong and capable Regulatory Affairs Organization in Brazil to properly respond to the business needs.

Sense and influence the external regulatory environment to anticipate new regulatory requirements, regulation and trends and map the impacts to BD. Develop and define the strategy to address them.

Define and implement strategy for product registration and product lifecycle management for BD Brazil to support business growth.

**Job Description**:
**How about belonging to a leading global medical technology company that acts to advance the world of health? Be part of something bigger**
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.

**Key Responsibilities**:

- Lead and develop the Regulatory Affairs Team focused on talent acquisition, retention and succession plan. Identify the potential talents and intentionally plans for their development (assignments and skills development) through a well-planned and timed set of opportunities
- Provides Regulatory Affairs guidance to the Functions and Businesses to build and increase regulatory awareness and understanding across BD
- Actively participation at local Industry Association meetings and events to advocate on behalf of BD and to monitor, sensing and influence the regulatory environment.
- Assure the Company complies with Local Regulatory Affairs requirements and regulations and with Corporate Regulatory Affairs policies and procedures.
- Develop and maintain the main metrics for the RA function and for finance (ASR, budget and forecast) duly updated to ensure periodic reports will be readly available for monitoring and tracking purposes.
- Ensure the regulatory activities are aligned with the Hub and global strategies and priorities to manage product registration, re-registration and changes process in a timely manner.
- Provide active support to the Regulatory Affairs Director on tactical and strategic matters.
- Provide regulatory expertise and guidance on complex matters, define the impact to the company and strategies to overcome them, assuring a good line of communication with the RA Function, CGM, BU leaders and affected functions.
- Lead the regular activities of local RA Team and consultants to ensure activities and priorities are aligned with the Function/Hub/Businesses and local requirements in order to meet the commitments.

**Requirements**:

- Education: Pharmacy, Biochemistry or other Health Sciences (Bachelor)
- Desired: Post-graduation in Business Administration, People Management, Project Management, Regulatory Affairs Science or Quality Science.
- Solid experience working with Regulatory Affairs in Medical Devices segment.
- Strong expertise & experience as Regulatory Affairs Leader with people management
- Language requirements: English (advanced, oral and written communication)
- Others: Good skills on Microsoft tools (word, excel and powerpoint)
- “BD values equity in the workplace without discrimination for any disability, class, ethnicity, age, religion, gender identity or sexual orientation.”**Primary Work Location**:BRA Sao Paulo - Chacara Santo Antonio

**Additional Locations**:
**Work Shift**: