Regulatory Manager (CMC and Biologics)

Regulatory Manager (CMC and Biologics) 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. Discover what your 25,000 future colleagues already know: Why Syneos Health • 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.  • We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.  Job Responsibilities Min of 10+ yrs of Biologics + CMC experience  Experience in Biologics, Biosimilars, and CMC. Strong expertise in Regulatory Intelligence across various global markets. Hands-on experience in Module 3 authoring and dossier preparation. Knowledge of regulatory submission strategies and compliance requirements. Extensive experience in product lifecycle management. Managed both pre-licensing and post-licensing regulatory activities. Experience in preparing and maintaining regulatory documentation for health authority submissions. Familiar with market-specific regulatory requirements and change management processes. Strong understanding of CMC variations, amendments, and renewals. Open to exploring opportunities in Small Molecules in addition to Biologics and Biosimilars. JOB RESPONSIBILITIES  Contributes to planning for regulatory submissions in assigned region/country/project.  Responsible for day to day management of project teams and projects.  Line management responsibilities for staff members. For direct and indirect reports, may participate in and manage activities related to department staff operations such as interviewing and selection, job