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 Position ID: bt-sraregops-m
Job Category: Biotech/R&D/Science
Type: Full Time, Temporary/Contract/Project
Minimum Education: Bachelor's Degree
Senior Associate/ Associate, Regulatory Operations Our client is an entrepreneurial pharmaceutical company focused on the development of medicines to target important human needs. They are experiencing significant growth and recently received positive results from a phase III trial for their lead compound. This is a great opportunity to join a company that offers potential for you to leverage your experience and take your career to the next level while working with a world-class drug discovery team. Job Responsibilities: - Assist with the development and implementation of systems and procedures used to support regulatory submission activities (eCTD production, document publishing, and document management).
- Evaluate current processes and systems with regard to industry best practices
- Propose changes targeting greater efficiency and continued compliance
- Support the transition from legacy to eCTD submissions
- Represent Regulatory Operations by participating on assigned teams to support submission scheduling and ensure coordination of system development activities
- Develop proposals for system and process development to support greater efficiency and continued regulatory compliance
- Support compliance with worldwide submission regulations and guidelines
Job Requirements: - 6 years of pharmaceutical industry experience
- 4 years of experience compiling electronic submissions
- Experience compiling IND, NDA/BLA, and CTD submissions
- Understanding of eCTD submission requirements
- Advanced skills with submission publishing software
- Bachelor's degree or equivalent experience
Compensation: $76,000 (Compensation commensurate with experience and salary history).Complete benefits package, stock options and relocation. For confidential consideration, please forward your resume in a Word document to: bthornton@kleinhersh.com Visit www.kleinhersh.com to view other job opportunities available through our company.
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