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.
Qualifications
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
Syneos Health Looking for latest chemistry and Pharma job openings, follow Rasayanika Facebook and Telegram and subscribe to our youtube channel for the latest updates on chemistry and Pharma job
