Senior Regulatory CMC Consultant - Small Molecule, Veeva RIM

🕒 September 17

🌐 Argentina, Ukraine, +3 more countries – Remote

🇦🇷 Argentina – Remote 🇺🇦 Ukraine – Remote 🇨🇦 Canada – Remote 🇷🇸 Serbia – Remote 🇧🇷 Brazil – Remote

⏰ Full Time

🟠 Senior

🚔 Compliance

👻 Ghost score 23%

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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 the execution of global regulatory CMC strategies for marketed and development products • Contribute to the preparation and submission of regulatory CMC documentation for small molecules • Review CMC sections of regulatory submissions, interactions, and responses with regulatory agencies • Contribute to global regulatory CMC strategies for commercial products • Work with regulatory colleagues to develop global regulatory CMC strategies and submissions • Provide regulatory CMC guidance to cross-functional teams and key stakeholders • Support regulatory assessment and guidance on product compliance topics, including change controls, deviations, and GMP investigations

🎯 Requirements

• Strong interpersonal skills to exchange complex information with others and to guide others • Proficiency in regulatory FDA, EMA, Health Canada, LATAM, Middle East, and ICH guidelines • Experience in the preparation, including writing, of CMC submissions • Strategic thinking and strong problem-solving skills • Ability to collaborate and communicate in an open, clear, complete, timely, and consistent manner • Strong planning and prioritization skills • Ability to work with all levels of management • Ability to resolve complex and ambiguous situations • Sound knowledge of cGMP, FDA, EMA, and ICH • Bachelor's degree, with a preference in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices, or another related life-science field • Equivalent experience, skills, and/or education may be considered

🏖️ 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

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