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.Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHEREWhy Syneos HealthWe 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. Why? Because 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 ResponsibilitiesContributes 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, including interviewing, selection, job description preparation, professional development, goal setting, performance management, coaching and mentoring, employee counseling, and separations.Acts as a representative of the regulatory department with other departments.Supports business development, including generation of repeat business from existing clients and proposal development.Develops, reviews, and monitors project budgets; reviews client invoicing.Monitors personal utilization and utilization of direct reports.Acts as a key point of contact for clients and regulatory authorities.Provides regulatory advice to Company associates.Conducts regulatory research on projects as needed.Provides strategic and operational advice to clients.Arranges, leads, and reports on client and regulatory agency meetings.Writes IND and product registration dossiers, clinical reports, and other regulatory documents. Manages project teams and preparation of regulatory submissions for conduct of INDs, product registrations, and post-approval maintenance activities.Acts as a resource for technical knowledge.Participates in quality improvement efforts to increase overall operational efficiency.Contributes to the building of 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, association meetings, authoring articles for trade journals, and participation in industry associations through memberships and on committees.Develops solutions to complex problems.Provides internal training in appropriate areas of expertise to other departments.QualificationsWhat We're Looking ForBS degree, preferably in a science-related field or equivalent experience in science/regulatory/medical writing-related field or moderate pharmaceutical/medical device related experience.Demonstrated experience in contributing to the preparation of regulatory submissions including IND, PMA, NDA, MAA, and CTD, including electronic submissions.Comprehensive regulatory knowledge and understanding of pharmaceutical and or medical device product development.Excellent interpersonal/communication skills including excellent written and verbal communication skills.Excellent customer service skills, with the ability to work both as a team member and independently.Good quality management and budgeting skills.Good people management, project management, problem-solving, and decision-making skills.Advanced skills in Microsoft Office Applications.Ability to interact with staff from multiple departments and offices to establish project standards.Good initiative, adaptability, and pro-activity.Strong analytical skills, good attention to detail.Ability to work concurrently on projects, each with specific instructions that may differ from project to project.Fluent in speaking, writing, and reading English.Get to Know Syneos HealthOver 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.Additional Information: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.At Syneos Health, we are dedicated to building a diverse, inclusive and authentic workplace. If your past experience doesn't align perfectly, we encourage you to apply anyway. At times, we take into consideration transferable skills from previous roles.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.
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