Regulatory Associate

**Description**

**Regulatory Associate**

Come discover what our 25,000+ employees already know: work here matters everywhere. We’re a growing and evolving biopharmaceutical industry leader, which means you’ll have endless opportunities to work with experts around the world and build the career you’ve dreamed of.
As a part of the Syneos Health team, you’ll help us deliver results for a rewarding reason - we improve patients’ lives around the world. Because to us, a patient isn’t just a number, they’re our family, friends, and neighbors.

**Why Syneos Health**
- #SyneosHealthLife means we’re committed to our Total Self culture - where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person’s unique contributions make a difference.
- We believe our success is a direct result of the people who are driving it - you We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That’s 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 - we’re able to create a place where everyone feels like they belong.

**Job responsibilities**
- Assists with preparation of product development documents including gap analyses and clinical development plans.
- Conducts regulatory research to identify regulatory precedents and to support the preparation of orphan drug designation requests.
- Performs quality checks on related documents.
- Assists with submissions of other regulatory documents and other regulatory research as needed.
- Assists clients, customers, or others with general information
- Gathers, compiles, analyzes, and reports information.
- Gathers information, searches files and records, and makes personal contacts to obtain specific information in order to prepare detailed reports and compose routine correspondence.

**Qualifications**

**What we’re looking for**
- BS in science/healthcare field, or equivalent combination of education and experience.
- Minimum 2-4 years of experience in writing Module 3 (CMC)
- Initiate and compile submissions, renewals, and variations for life cycle maintenance
- Exposure EU, US, Australia, Canada, Japan,China, Brazil market 3 CMC authoring (Any market)
- Sound knowledge of ICH guidelines and submission requirements of various markets such as USFDA, EMA etc.
- Good understanding of manufacturing and all aspects related to product development
- Advanced skills in Microsoft Office Applications. Excellent interpersonal / communication skills.
- Good time and project management skills, preferred.
- Strong analytical skills and attention to detail.
- Ability to work both as a team member and independently and to understand and carry out detailed instructions.
- Ability to interact with staff from multiple departments.
- Ability to work concurrently on projects, each with specific instructions that may differ from project to project preferred.
- 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 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.