Regulatory Consultant - CMC (CMC with small molecule products)

Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress. Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need.

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. Central to this is our purpose – 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.

The Chemistry Manufacturing Control Consultant will support the execution of multi-product global regulatory CMC for marketed products for small molecule products. This role contributes to the preparation and submission of regulatory CMC documentation and 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.
• Review CMC sections of regulatory submissions, as well as the interactions and responses 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.

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. Further, nothing contained herein should be construed to create an employment contract.