Regulatory Manager (labelling)

Regulatory Manager (labelling) 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 Should have min 8+ yrs of relevant experience. End to End CCDS updates based on the confirmed Safety signals Aware of the basic process, steps, leading cross-functional discussions and CCDS approval via Safety review committees Updates to CCDS based on the Clinical non-clinical studies results, Abbreviated PI’s Management of the EU QRD’s for MRP/DCP/CP and USPI’s for Safety submissions Experience with handling of PSUSA/PRAC and linguistic reviews Driving the labeling updates for ROW markets and artwork implementations Follow up with regional teams and Coordination with QP release sites Handling of the Health Authority mandated Safety proposals and deviations 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 description preparation, professional development, goal setting, performance management, coaching and mentoring, employee counseling, and separations.