Regulatory Associate

Syneos Health

1 - 6 years

0 Lacs

Gurugram

Posted:23 hours ago| Platform:

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Skills Required

Medical affairs Pharmacy Project management Agile clinical development Healthcare HTTP Regulatory affairs Internship Recruitment

Work Mode

Work from Office

Job Type

Internship

Job Description

Regulatory Associate (EU Market) Homebased

Job Responsibilities

Minimum 1 year of experience in Global Regulatory Affairs.
Hands-on experience in the preparation and review of global CMC dossiers, variation applications, and post-approval changes.
Solid understanding of regulatory markets and authorization dossier applications across regions including: EU, US, LATAM, APAC, Middle East, Africa, and China.
Proven ability to work effectively in a fast-paced, team-oriented environment.
Strong aptitude and attitude to learn and grow within the regulatory domain.
Candidates with internship experience in Regulatory Affairs (CMC) will be given preference.
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 authorization 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:

Masters in Pharmacy (Preferred)or Masters 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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