Senior Regulatory CMC Consultant – Small Molecule, Veeva RIM

🔥 7 minutes ago

🌐 United States, Canada – Remote

🇺🇸 United States – Remote 🇨🇦 Canada – Remote

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $56.4k - $115.1k / year

⏰ 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

• Execute commercial Lifecycle Management (LCM) strategy and submissions with a focus on US/CA/EU • Review CMC sections of regulatory submissions, 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

🎯 Requirements

• Bachelor's degree, preferably 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 • Preferred experience supporting Small Molecule programs • Must-have experience with Veeva RIM • Proficiency in FDA, EMA, Health Canada, and ICH regulatory guidelines • Sound knowledge of cGMP, FDA, EMA, and ICH • Strong interpersonal, problem-solving, collaboration, communication, planning, and prioritization skills • Ability to work with all levels of management

🏖️ Benefits

• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition and total rewards program • Company car or car allowance • Medical, dental, and vision benefits • Company match 401(k) • Eligibility to participate in Employee Stock Purchase Plan • Eligibility to earn commissions/bonus based on company and individual performance • Flexible paid time off (PTO) • Sick time