Regulatory Operations Associate

Functional area: Regulatory Operations

Position description:

This position will also be responsible for participating in day-to-day Regulatory Operation activities in support of the company’s goals.

Responsibilities:

• Represent Regulatory Operations by participating on assigned teams to support submission scheduling and ensure coordination of system development activities;
• Provide detailed project timeline information to supervisor to support resource forecasting;
• Coordinate and participate in the production of electronic regulatory submissions and, as required, paper submissions;
• Develop proposals for system and process development or modification to support greater efficiency and continued regulatory compliance;
• Assist with the development and implementation of processes related to submission standards, working practices, and quality controls;
• Support and conduct cross functional training on submission standards and procedures as required;
• Support compliance with worldwide submission regulations and guidelines.

Basic qualifications:

• Demonstrated skills managing project timelines and organizing supporting resources;
• Understanding of U.S. submission requirements;
• 1 years of pharmaceutical industry experience;
• 1 years of experience compiling electronic submissions;
• 1 years of experience in electronic document publishing;
• Experience compiling IND, NDA/BLA, and CTD submissions;
• Understanding of eCTD submission requirements;
• Excellent communication and interpersonal skills;
• Demonstrated ability to work well with cross functional teams;
• Bachelor’s degree or equivalent experience;
• Superb organizational skills and attention to detail;
• Demonstrated ability to manage priorities and work under tight timelines.

Preferred qualifications:

• Understanding of international requirements
• Proficient with Microsoft Office products and Adobe Acrobat;
• Advanced skills with submission publishing software;
• Extensive experience using electronic document management systems;
• Familiarity with system validation practices;

Contract: 6 month contract, strong possibility of extension or permanent.

Preferred Experience:

• B.S. w/ 1 + years of pharmaceutical experience
• 1 years of experience compiling electronic submissions
• 1 years of experience in electronic document publishing
• Adobe Acrobat / Word
• Conversions, pdf conversions, bookmarking, linking

Hiring Process:

Phone Interview w/ Manager

Onsite w/ 3-4 team members