Sr Regulatory Consultant (CMC and Biologics)

Sr Regulatory Consultant (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 6–9 years of Regulatory experience, preferably in biologics. IND- Gurugram / Hyderabad Strong expertise in authoring and reviewing Module 3 CMC sections for post-approval variations and lifecycle activities. Experience handling EU and ROW CMC variation submissions. Hands-on experience with Drug Substance, Drug Product and site transfer variations. Strong knowledge of global regulatory requirements, with EU market experience mandatory. Ability to work independently, resolve issues proactively, and manage multiple priorities in a fast-paced environment. JOB RESPONSIBILITIES Responsible for day-to-day contribution to project teams and projects. Acts as a representative of the GRAS regulatory department with other departments. Contributes technical expertise to proposals and assists with Business Development initiatives. Understands project budgets, scope of projects, allocated hours, and tracks compliance. Interacts with internal and external personnel, clients, and technical experts on projects. Conducts regulatory research on projects as needed. Provides operational advice to clients. Prepares consulting reports under guidance. Arranges, leads, and reports on client meetings.