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Syneos Health
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Associate RA ( Module 1, regulatory submission)

Associate RA ( Module 1, regulatory submission)

Syneos Health

2 - 7 years

4 - 9 Lacs

gurugram

Posted:None| Platform:

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Skills Required

administration medical affairs pharma project management agile clinical development http archiving document management recruitment

Work Mode

Work from Office

Job Type

Full Time

Job Description

Associate RA ( Module 1, regulatory submission)

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

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 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 - preparing responses to Health Authority queries and tracking HA commitments etc., 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 in order to prepare detailed reports and compose routine correspondence.

QUALIFICATION REQUIREMENTS

Masters in pharmaceutical sciences.
Minimum around 2 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.

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