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
- 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.