Regulatory CMC Manager

We have been engaged to find top-tier candidates for a newly created Regulatory CMC Manager (or Sr. Associate) position.  My client is a commercial-stage pharmaceutical company which is committed to transforming the lives of patients with cancer and rare genetic diseases. In this position, you will contribute to Regulatory CMC strategies for a portfolio of small molecule drugs, write CMC sections, and work closely with health authorities. With two approved programs and multiple investigational therapies in development, now is an ideal time to join this growing company!

Responsibilities:

  • Contribute to and execute on regulatory CMC strategies for a portfolio of small molecule drug candidates and approved products.
  • Plan, write and review CMC sections for INDs, CTAs, NDAs, amendments, and life-cycle management submissions.
  • Work directly with Regulatory Authorities on CMC and project-related matters.
  • Provide regulatory CMC expertise to cross-functional teams.
  • Review and approve technical documentation in support of CMC and QA activities and assess regulatory impact for development process changes.
  • Conduct some post-approval CMC regulatory activities such as change controls as needed.
  • Provide insight and guidance on implementation of current regulations with respect to the preparation and submission of CMC regulatory documentation as a member of internal Project Teams

Requirements:

  • S. in a scientific discipline; advanced degree (MS, PhD, Pharm D) preferred.
  • 3-5 years of experience in Regulatory CMC for pharmaceutical drugs.
  • Direct experience writing and managing CMC sections for INDs and or CTAs for drug development programs. NDA experience is a plus.
  • Experience working with health authorities (FDA, EMA, Health Canada, etc).
  • Solid knowledge of drug development; FDA, EMA and ICH CMC guidelines and regulations; and current Good Manufacturing Practices (cGMP).
  • Strong organizational skills and attention to detail.
  • Excellent verbal and written communication skills.
  • Ability to work both independently and in a team environment.
  • Positive attitude, energetic and proactive.
  • Proven ability to manage multiple projects, identify and proactively resolve regulatory issues.

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