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Syneos Health
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Regulatory Associate

Regulatory Associate

Syneos Health

2 - 4 years

4 - 6 Lacs

gurugram

Posted:1 day ago| Platform:

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Skills Required

analytical skills medical affairs project management agile clinical development healthcare http research ms office recruitment

Work Mode

Work from Office

Job Type

Full Time

Job Description

Regulatory Associate

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. WhyBecause 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

JOB RESPONSIBILITIES

Essential Functions

Assists with preparation of product development documents including gap analyses and clinical development plans.
Assists with preparation of regulatory submission documents including components of investigational new drug applications (INDs), new drug applications or new marketing applications (NDAs/MAAs), drug master files (DMFs), variations, renewals, marketing authorisation transfers (MATs) and other lifecycle maintenance activities, according to current government regulations and guidelines.
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.

QUALIFICATION REQUIREMENTS

BS in science/healthcare field, or equivalent combination of education and experience.
Excellent interpersonal / communication skills.
Advanced skills in Microsoft Office Applications.
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.

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