[Hiring] Regulatory Associate @Syneos Health

Role Description

This role involves supporting regulatory submissions and product development in the biopharmaceutical sector.

• Should have minimum 6 months to 2 years of experience
• Candidates with internship preferred
• Should have CMC experience in small molecule
• Markets experience in EU, GCC, APAC would be preferred

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 INDs, NDAs/MAAs, DMFs, variations, renewals, MATs, and other lifecycle maintenance activities
• 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

• 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

Additional Information

• Tasks, duties, and responsibilities as listed in this job description are not exhaustive
• The Company may assign other tasks, duties, and job responsibilities at its sole discretion and with no prior notice
• Equivalent experience, skills, and/or education will also be considered
• The Company will determine what constitutes as equivalent to the qualifications described above
• Nothing contained herein should be construed to create an employment contract
• The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations