Syneos Health Hiring Pharma D. & M Pharma Graduates - Apply Online

Syneos Health Syneos Health Hiring Regulatory Associate (Hiring Pharm D. & M Pharma Graduates on 6 Months Contract)

Location: India-Asia Pacific – IND-Home-Based

Job ID: 23005266

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.


What we’re looking for

  • 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.

Apply Online

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