Associate Ra

**Description**

Associate RA ( Module 3, CMC)

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.

**Responsibilities**:
**JOB RESPONSIBILITIES**

Essential Functions

For non-complex submissions, independently fulfill the following responsibilities. For complex submissions, fulfill the following responsibilities under supervision and with guidance from more senior regulatory colleagues:

- Prepares Module 3 sections for post-approval CMC variations, renewals, annual reports, legal entity name change variations and other lifecycle maintenance activities, according to current government regulations and guidelines
- Experience of performing activities in Veeva RIMS, including creation of objectives and submission content plans, would be preferred.
- Undertakes information processing activities with extremely high reliability at high quality and in tight timelines according to standard processes and operating procedures.
- Undertake project specific activities with mínimal supervision from senior colleagues within cost and time estimates/contracts.
- Preparation of records and/or logs and maintenance or update of regulatory databases as per Syneos Health and/or client requirements.
- Conducts Quality Control reviews of documents and sends out for review, tracks until final submission or delivery to client.
- Attends client meetings as needed and builds client relationship in support of projects and deliverables.
- Systematically reviews Regulatory Associates or other Senior Associate’s work, performance, and productivity tracking, coordinating with project manager and director for coordination of the project.
- Identifies risks to project delivery related to own workload and appropriate escalation. For identified non-complex issues, provide proposals for issue resolution.
- Assists in training and mentoring of team members depending upon project requirements.
- Maintenance of individual training records (Syneos Health or client related) and completion of all designated required training.

**Qualifications - External**

**What we’re looking for**
- MS/M.Pharm, or equivalent combination of education and experience.
- Minimum 6 months of experience for Regulatory Associate and minimum 1.5 years of experience for Sr Regulatory Associate role.
- Excellent interpersonal / communication skills.
- Advanced skills in Microsoft Office Applications.
- Hands-on experience on RIM systems such as Veeva RIMS and Trackwise, would be preferred.
- Strong analytical skills.
- Ability to work 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.
- 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,