Job Description

Description Sr Regulatory Consultant Come discover what our 25,000+ employees already know: work here matters everywhere. We\xe2\x80\x99re a growing and evolving biopharmaceutical industry leader, which means you\xe2\x80\x99ll have endless opportunities to work with experts around the world and build the career you\xe2\x80\x99ve dreamed of.
As a part of the Syneos Health team, you\xe2\x80\x99ll help us deliver results for a rewarding reason \xe2\x80\x93 we improve patients\xe2\x80\x99 lives around the world. Because to us, a patient isn\xe2\x80\x99t just a number, they\xe2\x80\x99re our family, friends, and neighbors.
Why Syneos Health

• #SyneosHealthLife means we\xe2\x80\x99re committed to our Total Self culture \xe2\x80\x93 where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person\xe2\x80\x99s unique contributions make a difference.
• We believe our success is a direct result of the people who are driving it \xe2\x80\x93 you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That\xe2\x80\x99s why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial.
• 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 \xe2\x80\x93 we\xe2\x80\x99re 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.

Qualifications
What we\xe2\x80\x99re looking for

• BS degree, preferably in a science-related field or equivalent experience in science/regulatory/medical writing-related field. PhD preferred.
• Moderate regulatory, pharmaceutical/medical device related experience.
• Demonstrated experience in contributing to the preparation of regulatory submissions including for example IND, PMA, NDA, MAA, and CTD, including electronic submissions. Experience in niche submissions such as ODD, PIP/PMP an advantage.
• 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 skills.
• 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 Health
We are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most. Learn more about Syneos Health. 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 . The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.