Senior Regulatory Consultant – LATAM, Biologics, CTA

🔥 18 hours ago

🌐 Argentina, Mexico, +2 more countries – Remote

🇦🇷 Argentina – Remote 🇲🇽 Mexico – Remote 🇨🇴 Colombia – Remote 🇧🇷 Brazil – Remote

⏰ Full Time

🟠 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

• Support execution of multi-product global regulatory CMC for marketed products • Contribute to preparation and submission of regulatory CMC documentation • Provide regulatory support to various cross-functional teams • Execute commercial Lifecycle Management strategy and submissions focused on US, Canada and EU • Review CMC sections of regulatory submissions and interactions and responses with regulatory agencies • Work with regulatory colleagues to develop global regulatory CMC strategies and submissions • Participate effectively on cross-functional teams • Serve as the primary regulatory CMC contact for assigned products and projects when applicable

🎯 Requirements

• Bachelor's degree, with a preference in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices, or another related life-science field • Typically requires 4 years of experience in the pharmaceutical industry or related field, or the equivalent combination of education and experience • Proficiency in regulatory FDA, EMA, Health Canada and ICH guidelines • Strong interpersonal skills to exchange complex information with others and to guide others • Strong problem-solving skills • Ability to collaborate and communicate in an open, clear, complete, timely and consistent manner • Strong sense of planning and prioritization, and the ability to work with all levels of management • Sound knowledge of cGMP, FDA, EMA, ICH • Biologics and CTA experience required by the job title

🏖️ 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, under the Americans with Disabilities Act