Regulatory Strategist – International, Manager

🔥 0 minutes ago

🇧🇷 Brazil – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

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Syneos Health

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.

📋 Description

• Lead and support submissions in Latin American markets for MAAs and life-cycle management procedures • Provide local expertise as a member of the Global Regulatory Affairs team and help establish and implement best practices • Drive and coordinate regulatory strategy and local regulatory activities in Latin America • Provide regional regulatory expertise for geographical expansion • Track Health Authorities’ requests and relevant new local regulations and forward them to the relevant GRA contact • Maintain current knowledge of local requirements and communicate regulatory changes to Regulatory Senior Management • Lead cross-functional teams in preparing submission activities from planning through submission and review, including responses to questions • Support submission leads by preparing timelines, creating submission binders, and maintaining submission and correspondence files • Act as local expert for regulatory queries from other functions, including medical and supply chain, on regulatory requirements, local labelling guidance, CTD, and GMPs • Ensure all work complies with regulatory requirements and company policies and procedures

🎯 Requirements

• Relevant industry experience in regulatory affairs in Latin America • Understanding of current trends in local and regional requirements • Recognized as a knowledgeable resource for regulatory advice by other departments • Experience interacting with Regulatory Authorities • Ability to facilitate interactions with International Regulatory Affairs, other departments within the Company, and external parties, mainly submission partners • Bachelor’s degree in Pharmaceutical Sciences • Advanced written and spoken English • Knowledge of Spanish and Portuguese considered an advantage

🏖️ Benefits

• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition • Total rewards program • Inclusive culture • Reasonable accommodations, when appropriate

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