Regulatory Consultant, CMC-EU, GCC, AU

🔥 3 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

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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

• Conduct research of existing product data relative to global or regional regulatory requirements for the preparation of gap analyses, product development plans, and other regulatory submissions. • Contribute to or prepare administrative and technical components of regulatory agency submissions. • Manage and/or operationalize the delivery of day-to-day regulatory activities for assigned projects according to agreed timelines and scope. • Participate as regulatory support on multidisciplinary project teams for product development throughout their life cycle. • Act as a subject matter expert to help team members with day-to-day troubleshooting activities. • Prepare estimates for conducting regulatory services as part of proposals. • Ensure compliance with global regulatory requirements and company policies. • Prepare training materials and share best practices in the regulatory area.

🎯 Requirements

• Experience in conducting research of existing product data relative to global or regional regulatory requirements • Proficiency in preparing administrative and technical components of regulatory agency submissions • Ability to manage and operationalize the delivery of regulatory activities for assigned projects • Experience in multidisciplinary project teams for product development • Strong presentation skills to present solutions to project related problems • Experience in preparing estimates for conducting regulatory services • Familiarity with compliance to appropriate global regulatory requirements and company processes. • Participation in internal or external project audits and support of internal cross-functional initiatives.

🏖️ Benefits

• We are passionate about developing our people, through career development and progression • supportive and engaged line management • technical and therapeutic area training • peer recognition and total rewards program • We are committed to building an inclusive culture – where you can authentically be yourself • Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life.