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Search for Jobs by Sheryl Horowitz

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Associate Director, CMC Regulatory Affairs (Science & Biotech)
Raleigh, NC 27601
Recruited by: Sheryl Horowitz | Owner | F-O-R-T-U-N-E Personnel Consultants, Inc. See all my Jobs

  • Hiring Company: F-O-R-T-U-N-E Personnel Consultants, Inc.
  • Industry: Science & Biotech
  • Compensation: Salary
  • Expires: Apr 06, 2019
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Job Description

Our client, a growing Oncology pharmaceutical company located in the RTP area, is currently hiring a new position for their growing team!

Primary Job Responsibilities:
• Lead efforts for coordinating CMC content for original INDs, IND amendments, IMPDs, for inclusion in Clinical Trial Applications and NDAs
• Participate in multidisciplinary efforts to prepare CMC updates for regulatory documents including Investigator Brochures, DSURs and background documents for Regulatory Authority meetings
• Provides strategic CMC regulatory interpretation and guidance to project teams
• Facilitate and deliver the regulatory strategy to support the lifecycle of assets (accountable for execution of CMC aspects).
• Manage and contribute to CMC projects, initiatives & actions along with prioritizing assigned workload appropriately.
• Manage project activities, present and articulate issues for resolution and execute as a scientific/technical resource for assigned projects.
• Serve as CMC representative on a cross-functional project(s) demonstrating ability to manage project activities, assess regulatory risks & development plans to develop global regulatory strategies for programs in accordance with regulatory, scientific & technical criteria.
• Manage regulatory issues, maintain submission information in relevant CMC systems, tracks regulatory commitments & timelines for specific projects/products/markets with minimal supervision.
• Serve as a technical and scientific resource within own work group/discipline and provides guidance for completion of difficult and complex projects.
• Develop relationships with regulatory authorities to improve regulatory success.
• May participate in pharmaceutical industry conferences or serve externally as a representative to pharmaceutical trade group advisory committees relevant to CMC functions.
• Demonstrate ability to present and articulate issues for resolution and execute as a scientific/technical resource for assigned projects.
• Develop effective relationships across the company, ensuring all regulatory activities for assigned products are executed effectively & efficiently in compliance with external regulatory requirements & internal quality procedures.
• Other duties as assigned.

Job and Level Requirements:
• B.S., M.S., or Ph.D. in Scientific related discipline; or acceptable complementary experience in the pharmaceutical/ biotechnology industry
• 7+ years’ regulatory experience with a minimum of 3 years hands-on CMC authoring experience (initial registrations or post-approval variations)
• Additional experience in a biologicals or biotechnology manufacturing environment e.g., QA or manufacturing or technical/product development a plus
• Experience operating within GMP, GLP, or GCP related SOPs
• Effective verbal & written communication skills in a cross functional environment
• Excellent project management skills
• Strong negotiation skills with internal and external stakeholders
• Extensive and proactive commercial awareness with evidenced application to regulatory strategies
• Excellent customer focus with demonstrated management of customer expectations and anticipating customer needs
• Demonstrated ability to take measured risks with overall positive outcome for the business
• Excellent presentation skills
• Ability to analyze data and understand and communicate opportunities and implications for the business