Principal Clinical Trial Regulatory Affairs, 4+ years in regulatory submissions

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🇺🇸 United States – Remote

⏰ Full Time

🔴 Lead

🚔 Compliance

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Syneos Health

WebsiteLinkedInAll Job Openings

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

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

• Collaborates as Regulatory Subject Matter Expert with major functional area leads to identify and evaluate fundamental issues pertaining to the Site Activation pathway. • Participates in strategic development activities including account/ portfolio client meetings. • Line management responsibilities for staff members. • Develops and maintains strategic relationships with customers in alignment with their assigned projects. • Ensures all project deliverables meet the internal and customers’ expectations as per contracted deliverables. • Prepares and communicates overall Regulatory strategy and status at client meetings. • Assumes accountability on the CTRA operations on specific project activities. • Reviews the project budget against project milestones and budget to ensure project profitability.

🎯 Requirements

• +4 years of experience in regulatory submissions in US/CAN • Bachelor’s Degree, Higher Degree Preferred. • Subject matter expertise in current regulation frameworks (e.g. regulations and guidelines specific for non - interventional studies, clinical trial and medical device regulations) • Experience in working to applicable GxPs (e.g. GVP, GCP, ISO 14155) etc • Strong knowledge of clinical research management processes. • Thorough knowledge of applicable regulations, drug development, and clinical project management procedures. • Previous experience in budgeting and quality management • Ability to teach/mentor team members. • Ability to coach employees to reach performance objectives. • Excellent communication and interpersonal skills (both written and spoken) with an ability to influence, convince and persuade as well as a team-oriented approach. • Quality-driven in all managed activities • Strong negotiating and problem-solving skills.

🏖️ 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.