Description

Regulatory Consultant - US - Submissions experience & Project Management experience required

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 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. 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 responsibilities

For non-complex and complex submissions, independently fulfill the following responsibilities: 

Create and Maintain Content Plans within Veeva Vault RIM  Translating Smartsheet timelines into Microsoft Project and Veeva Vault RIM  Assist with planning, managing, and tracking of regulatory submissions  Support Global Submission Managers with project management activities, tasks and tracking  Assist with coordination and communication of regulatory submissions to Publishing  Ability to work with firm deadlines and adapt quickly to changing requirements and priorities.  Excellent organization, written/verbal communication to explain difficult information, and attention to detail.  Submission Technology:  Proficiency in electronic submission tools and software, such as eCTD and regulatory information management systems.  Keywords:  Insight Publisher, Lorenz Publisher, Veeva Vault RIM, Content Planning, eCTD Viewers, DXC (ISI) Toolbox  Project Management Technology:  Experience and proficiency with project management tools and software.  Keywords:  Smartsheet, Microsoft Project, Excel, Office timeline Pro  Maintenance of individual training records (Syneos Health or client related) and completion of all designated required training.

Qualifications

What we’re looking for

B.S. (or equivalent experience) and 5+ years of Regulatory Affairs Work Experience, with a focus on publishing and/or submissions  M.S. (or equivalent experience) and 3+ years of Regulatory Affairs Work Experience, with a focus on publishing and/or submissions  In-depth understanding of regulatory requirements and guidelines including FDA regulations, EMA guidelines and ICH standards. Keywords:  eCTD, NDA, IND, EU CTA, MAA, EU CTR, NDS  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
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. 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 Job Description.  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.