Senior Regulatory Associate, CMC - EU, APAC, Gulf Countries

🔥 13 minutes ago

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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

• For non-complex submissions, independently fulfill the following responsibilities. • Prepares and submits full application or components of IND, marketing and lifecycle maintenance applications to ensure compliance with government acts and regulations. • Undertakes information processing activities with extremely high reliability at high quality and in tight timelines according to standard processes and operating procedures. • Undertake project specific activities with minimal supervision from senior colleagues within cost and time estimates/contracts. • Preparation of records and/or logs and maintenance or update of regulatory databases as per Syneos Health and/or client requirements. • Conducts Quality Control reviews of documents and sends out for review, tracks until final submission or delivery to client. • Attends client meetings as needed and builds client relationship in support of projects and deliverables. • Systematically reviews Regulatory Associates or other Senior Associate’s work, performance, and productivity tracking, coordinating with project manager and director for coordination of the project. • Identifies risks to project delivery related to own workload and appropriate escalation. • For identified non-complex issues, provide proposals for issue resolution. • Assists in training and mentoring of team members depending upon project requirements. • Maintenance of individual training records (Syneos Health or client related) and completion of all designated required training.

🎯 Requirements

• For non-complex submissions, independently fulfill responsibilities. • Prepares and submits full application or components of IND, marketing and lifecycle maintenance applications to ensure compliance with government acts and regulations. • Undertakes information processing activities with extremely high reliability at high quality and in tight timelines according to standard processes and operating procedures. • Undertake project specific activities with minimal supervision from senior colleagues within cost and time estimates/contracts. • Preparation of records and/or logs and maintenance or update of regulatory databases as per Syneos Health and/or client requirements. • Conducts Quality Control reviews of documents and sends out for review, tracks until final submission or delivery to client. • Attends client meetings as needed and builds client relationship in support of projects and deliverables. • Systematically reviews Regulatory Associates or other Senior Associate’s work, performance, and productivity tracking, coordinating with project manager and director for coordination of the project. • Identifies risks to project delivery related to own workload and appropriate escalation. • Assists in training and mentoring of team members depending upon project requirements. • Maintenance of individual training records (Syneos Health or client related) and completion of all designated required training.

🏖️ 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.