Senior RA Manager CMC

Highly Competitive Salary
  1. Permanent
  2. CMC
  3. United States
Denver, Colorado
Posting date: 19 Jul 2019

Proclinical is currently seeking a Senior Manager of Regulatory CMC for a clinical-stage biotechnology company, located remotely. Successful candidate will Act as a Regulatory Project Manager in planning, coordination and tracking CMC dossier for IND. Candidate will report to Vice President of Regulatory CMC.

Job Responsibilities:

  • Representing Regulatory Affairs CMC perspective to teams. Providing regulatory CMC guidance on FDA and global requirements to the team. Preparing and submitting high quality regulatory submissions to global health authorities in accordance with regulatory guidelines and applicable federal laws.
  • Preparing CMC sections of regulatory submissions for cell and gene therapy products in various phases of product development. Defining CMC content for high quality submissions.
  • Serving as Regulatory Affairs CMC Project Manager, liaising with cross functional departments; strategizing and planning for timely registration submissions in the Unites States and other countries assigned.
  • Working closely within the Regulatory department to prepare robust regulatory applications to achieve departmental and organizational objectives.
  • Serving as Regulatory Affairs CMC lead for assigned project in deliver high quality CMC dossier suitable for registration and subsequent post-approval CMC activities.
  • Working with Tech Ops team in providing regulatory CMC requirements and resolving technical issues.
  • Preparing CMC briefing package for various agency meetings.
  • Interacting with FDA under the guidance of department head.
  • Maintaining relevant cell gene CMC knowledge base of existing and emerging regulations, standards, or guidance and providing interpretive assistance to cross-functional teams.

Skills and Requirements:

  • Minimum of BS or equivalent. MS or PhD desired.
  • 5-7 years of CMC experience for biologics. 3+ years in Regulatory Affairs is required. Experience in cell/ gene therapy is preferred.
  • Capable of performing independently and thinking analytically and creatively to solve problems.
  • Recent experience in preparing CMC sections of INDs/BLAs for cell and gene therapy products is required. International regulatory experience is a plus.
  • Excellent communication and interpersonal skills required to enable optimal interactions both internally and externally.
  • Understanding of scientific principles and capable of interpreting regulatory requirements.
  • Demonstrated project management experience and can work in a cross-functional team environment to develop, implement and deliver on project goals.
  • Strong knowledge with MS Office applications, MS Project, SharePoint and Document Management System.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Nicholas Walker at (+1) 646-367-2908 or upload your resume on our website -

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.