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 Position ID: bt-rgafcmc-m
Job Category: Biotech/R&D/Science
Type: Full Time, Employee
Salary: 90,000.00 - 115,000.00 USD /year
Minimum Education: Bachelor's Degree
Manager/Sr Manager/Associate Director Regulatory Affairs CMC 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: - Responsible for developing and implementing CMC regulatory strategies
- Coordinate all aspects of CMC regulatory submissions.
- Serve as the regulatory CMC representative on project teams and be involved with products throughout their life cycle.
- Lead activities, including planning, writing, and reviewing CMC (chemistry, manufacturing and control) sections of all regulatory submissions (INDs, NDAs, CTXs) -Coordinate the preparation of responses to regulatory agencies
- Access and communicate CMC regulatory requirements to ensure all development activities are in compliance with applicable regulations and guidelines;
Job Requirements: - 5-8 years of industry experience in pharmaceutical product development
- Minimum of 3-5 years in preparing and supporting chemistry, manufacturing and control (CMC) documentation for regulatory filings
- Bachelors Degree in chemistry, biochemistry, or related pharmaceutical science required; advanced degree helpful
- Solid working knowledge of drug development process and knowledge of FDA regulatory requirements; E.U., Canada, and ROW experience desirable
Compensation: $90,000-115,000 (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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