# Regulatory Strategist - Intl (Mgr)

**Company**: Syneos Health
**Location**: BRA-Remote
**Work arrangement**: remote
**Experience**: senior
**Job type**: full-time
**Category**: Policy & Public Affairs
**Industry**: Healthcare

**Apply**: https://syneoshealth.wd12.myworkdayjobs.com/en-US/Syneos_Health_External_Site/job/BRA-Remote/Regulatory-Strategist_25111935?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_91534c21-55b

## Description

Syneos Health is seeking a Regulatory Strategist - Intl (Mgr) to lead and support submissions in Latin American Markets for MAAs and life-cycle management procedures. The successful candidate will provide local expertise as a member of the Global Regulatory Affairs (GRA) team and establish and implement best practices.

**Job Responsibilities**

The Regulatory Affairs Manager will drive and coordinate regulatory strategy and local regulatory activities in Latin America and provide regional regulatory expertise for geographical expansion. Key duties include:

- Tracking all Health Authorities' requests and relevant new local regulations

- Maintaining current knowledge of local requirements and anticipating, assessing, and communicating changes to Regulatory Senior Management

- Leading cross-functional teams to prepare submission activities

- Acting as support to submission lead and preparing timelines and submission binders

- Providing local regulatory expertise and maintaining current knowledge of local requirements

- Acting as local expert for regulatory queries from other functions

- Ensuring all work is compliant with regulatory requirements and company policies and procedures

**Regulatory Experience & Education Requirements**

The ideal candidate will have:

- Relevant industry experience in regulatory affairs in Latin America

- Recognized expertise in regulatory advice

- Experience interacting with Regulatory Authorities

- Ability to facilitate interactions with International Regulatory Affairs and external parties

- Bachelor's degree in Pharmaceutical Sciences

- Advanced written and spoken English and knowledge of Spanish and Portuguese

**What We Offer**

Syneos Health offers a range of benefits, including career development and progression, supportive line management, technical and therapeutic area training, and total rewards programs.

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## Skills

### Required
- regulatory affairs
- Latin American markets
- MAAs
- life-cycle management
- Health Authorities
- regulatory strategy
- local regulatory activities
- Pharmaceutical Sciences
- English
- Spanish
- Portuguese

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Source: [Apply at syneoshealth.wd12.myworkdayjobs.com](https://syneoshealth.wd12.myworkdayjobs.com/en-US/Syneos_Health_External_Site/job/BRA-Remote/Regulatory-Strategist_25111935?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)