Regulatory Strategist

Job not on LinkedIn

🔥 0 minutes ago

🇨🇦 Canada – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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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 lifecycle management procedures • Provide local regulatory expertise as a member of the Global Regulatory Affairs team • Drive and coordinate regulatory strategy and local regulatory activities in Latin America • Provide regional regulatory expertise for geographical expansion • Track Health Authority requests and relevant new local regulations • Maintain knowledge of local requirements and communicate regulatory changes to senior management • Lead cross-functional teams through submission planning, preparation, submission, and review • Prepare responses to regulatory questions • Prepare timelines and create submission binders in Veeva • Keep submission and correspondence files up to date • Act as local expert for regulatory queries from medical, supply chain, and other functions • Ensure compliance 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 regulatory requirements • Knowledgeable resource for regulatory advice • Experience interacting with Regulatory Authorities • Ability to facilitate interactions with International Regulatory Affairs, internal departments, and external parties/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