Regulatory Strategist - Intl (Mgr)

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.