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

🔥 37 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

• Independently fulfill responsibilities for non-complex submissions • Prepares and submits full application or components of IND • Conduct Quality Control reviews of documents • Attend client meetings as needed • Identify risks to project delivery • Assist in training and mentoring of team members.

🎯 Requirements

• Experience in regulatory submissions • Ability to work under tight timelines • Prepare and submit applications and documentation • Quality control review of regulatory documents • Build client relationships • Training and mentoring of team members.

🏖️ Benefits

• Health insurance • Career development and progression programs • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition • Total rewards program.