Senior Regulatory CMC Consultant – Small Molecule, Veeva RIM

🔥 13 minutes ago

🌐 United States, Canada, +2 more countries – Remote

🇺🇸 United States – Remote 🇨🇦 Canada – Remote 🇧🇷 Brazil – Remote 🇦🇷 Argentina – Remote

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

⏰ Full Time

🟠 Senior

🚔 Compliance

🦅 H1B Visa Sponsor

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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

• Provide regulatory CMC consulting for small molecule products using Veeva RIM • Assess and understand regulatory guidelines • Understand and support requirements and processes to maintain products on market, including reporting and surveillance • Apply knowledge of North America regulatory affairs framework • Plan, prioritize and contribute to work and projects in a systematic and efficient manner • Collaborate effectively within a team environment • Perform other tasks, duties, and responsibilities as assigned

🎯 Requirements

• Good knowledge of North America regulatory affairs framework • Understanding of requirements and processes to maintain a product on market, report, and surveillance • Understanding of drug development and related concepts • Ability to assess and understand regulatory guidelines • Strong written and verbal communication skills • Ability to work effectively within a team environment • Ability to plan, prioritize and contribute to work and projects in systematic and efficient manner • Bachelor's, Master's or PhD degree, with a preference in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices, or another life-science field • Typically requires 8 years of experience in the pharmaceutical or biotech industry or in a related field, or the equivalent combination of education and experience

🏖️ Benefits

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

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