Senior Regulatory Associate (Module 1)

Syneos Health, Inc.; Indianapolis (IN); On-site; USD 60,000 - 80,000; Full time

Job summary

A leading biopharmaceutical solutions organization located in Indianapolis is seeking a regulatory support professional. You will assist with the preparation of regulatory submission documents and ensure compliance with internal SOPs. The ideal candidate has a Master's in pharmaceutical sciences and at least 4 years of relevant experience, along with advanced skills in Microsoft Office. This role offers the opportunity to contribute to vital therapies and improve patients' lives.

Benefits

Career development and progression

Supportive line management

Total rewards program

Qualifications

• Minimum around 4 years of experience in a regulatory, quality, or document management support role.
• Experience in preparing regulatory submission documents.
• Conducts regulatory research to support orphan drug designation requests.

Responsibilities

• Assists with preparation of regulatory submission documents including INDs and NDAs.
• Maintains and updates regulatory trackers and submission timelines.
• Ensures proper archiving of submission documentation.

Skills

Excellent interpersonal / communication skills

Advanced skills in Microsoft Office Applications

Good time and project management skills

Education

Masters in pharmaceutical sciences

Job description

Overview

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 puts the customer and patient at the center of everything we do. We are continually seeking ways to simplify and streamline our work to make Syneos Health easier to work with for both our clients and our teams.

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 about changing 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 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 create a place where everyone feels they belong.

Job Responsibilities

• Essential Functions
• Assists with preparation of Module 1 documents and collection of country-specific administrative forms.
• Assists with preparation of regulatory submission documents including components of INDs, NDAs/MAAs, DMFs, variations, renewals, MATs and other lifecycle maintenance activities; prepares responses to Health Authority queries and tracks HA commitments according to current government regulations and guidelines.
• Maintains and updates regulatory trackers, submission timelines, and status reports.
• Ensures proper archiving of submission documentation and compliance with internal SOPs.
• Conducts regulatory research to identify regulatory precedents and to support the preparation of orphan drug designation requests.
• Assists clients, customers, or others with general information.
• Gathers information, searches files and records, and makes personal contacts to obtain specific information to prepare detailed reports and routine correspondence.

Qualification Requirements

• Masters in pharmaceutical sciences.
• Minimum around 4 years of experience in a regulatory, quality, or document management support role. Excellent interpersonal / communication skills.
• Advanced skills in Microsoft Office Applications.
• Good time and project management skills, preferred.

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.

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.

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 and consider transferable skills from previous roles. We also encourage you to join our Talent Network to stay connected to additional career opportunities.

Discover what our 29,000 employees already know: work here matters everywhere. We work hard and smart, all in the name of getting much-needed therapies to those who need them most. A career with Syneos Health means your everyday work improves patients’ lives around the world. Choosing us as an employer means a career with opportunities to grow.

Syneos Health® (Nasdaq: SYNH) is a leading 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. We support a diverse, equitable and inclusive culture.

Phone: [phone]
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Toll-Free: 866 462 7373

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: [e-mail]. One of our staff members will work with you to provide alternate means to submit your application.