Regulatory Consultant – CMC, Small Molecule Products

🕒 June 20

🇬🇧 United Kingdom – 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

• Support the execution of multi-product global regulatory CMC for marketed products for small molecule products. • Contribute to the preparation and submission of regulatory CMC documentation. • Provide regulatory support to various cross functional teams. • Execute commercial Lifecycle Management (LCM) strategy and submissions with a focus on Middle East and North Africa. • Review CMC sections of regulatory submissions and interactions with regulatory agencies for small molecule products. • Work with regulatory colleagues in development of global regulatory CMC strategies and submissions. • Participate effectively on cross-functional teams and may serve as the primary regulatory CMC contact for assigned products and projects.

🎯 Requirements

• Support the execution of multi-product global regulatory CMC for marketed products for small molecule products. • Contributes to the preparation and submission of regulatory CMC documentation. • Provides regulatory support to various cross functional teams. • Execute commercial Lifecycle Management (LCM) strategy and submissions with a focus on Middle East and North Africa. • Reviews CMC sections of regulatory submissions, as well as the interactions and responses with regulatory agencies for small molecule products. • Works with regulatory colleagues in development of global regulatory CMC strategies and Submissions.

🏖️ 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.