Senior Regulatory Consultant

Updated: YesterdayLocation: Mexico CityJob ID: 25104643 Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. 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 accelerate the delivery of therapies, because we are passionate to change lives. WORK HERE MATTERS EVERYWHERE 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 our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. When we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong. 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. Contributes to regulatory agency meetings. Writes IND and product registration dossiers, clinical reports, and other regulatory documents for submissions. Prepares full regulatory submissions for INDs, product registrations, and post‑approval maintenance activities, and participates on project teams. Acts as a resource for technical knowledge. Participates in quality improvement efforts to increase overall operational efficiency. Contributes to the building of the regulatory systems and infrastructure needed for GRAS. Develops reputation for the Company as industry leader in Regulatory by attending and speaking at industry events such as seminars and association meetings, authoring articles for trade journals, and participating in industry association through memberships and on committees. Provides internal training in appropriate areas of expertise to other Departments. May act as a Line Manager to a small team, dependent on the location. Performs other work‑related duties as assigned. Minimal travel may be required (up to 25%). Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever‑changing environment. Summary Responsible for the development of regulatory submissions in the Latin America region for post‑marketing regulatory support for clients. This includes authorship of portions of regulatory submissions, regulatory writing, regulatory research, and ensuring compliance with relevant guidelines and standards. Responsible for providing advice and assistance to clients and other associates in areas of expertise and may manage smaller client projects. Supports new business development in area of expertise. Contact Phone: 919 876 9300Fax: 919 876 9360Toll‑Free: 866 462 7373 Equal Opportunity Employer Syneos Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, marital status, ethnicity, national origin, sex, gender, gender identity, sexual orientation, protected veteran status, disability or any other legally protected status and will not be discriminated against. If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, including the use of this website, please contact us at Email: jobs@syneoshealth.com. One of our staff members will work with you to provide alternate means to submit your application. #J-18808-Ljbffr