Regulatory CMC Director

This growing biopharma company is developing a portfolio of gene therapy programs for the treatment of rare and severe diseases.  They are seeking a Regulatory CMC Director to lead Regulatory CMC strategies for multiple gene therapy programs in development. This is a hands-on role requiring strong knowledge and experience in writing CMC sections for INDs, CTAs, BLAs and MAAs. You will work closely with cross functional teams and other members of the Regulatory team while also interfacing with health authorities. This company offers a collaborative environment, competitive compensation, excellent benefits and equity. Now is an exciting time to join this growing organization and make an impact on the lives of patients in need!

Responsibilities:

  • Serve as Regulatory CMC lead for assigned projects, including, but not limited to the development and implementation of regulatory CMC strategy for assigned projects.
  • Provide CMC regulatory guidance for global development and registration programs (e.g. IND/IMPD/CTAs, NDA/BLA/MAAs).
  • Attend internal meetings as well as regulatory agencies meetings
  • Assess and communicate CMC regulatory requirements to ensure all development activities are in compliance with applicable regulations and guidelines.
  • Prepare and deliver CMC dossiers, either with CMC functional areas or hands-on, for clinical trial and registration applications, supplements, amendments and variations.
  • Manage the review, comments resolution and approval process to ensure that submissions are ready for transfer to the Regulatory Operations team.
  • Manage and ensure compliance with all reporting requirements, including annual and periodic reports.
  • May manage contract staff and vendors as needed to support Regulatory activities.

Qualifications:

  • BS degree in a scientific field.  Advanced degree (MS, PhD, Pharm D) preferred.
  • Ten or more years of experience in Regulatory CMC for development programs. Experience working on biologic programs is required. Gene therapy experience is highly desired.
  • Experience with preparing CMC sections of INDs, IMPDs, BLAs and/or MAA submission(s) is essential.
  • Established knowledge of regulatory CMC guidelines and regulations (US and international)
  • Prior experience in agency engagement and interaction.
  • Regulatory experience with development projects and marketed products.
  • Prior hands on experience of FDA CMC regulatory submissions is essential.
  • Strong knowledge of eCTD elements and structure and regulatory writing skills.
  • Possesses strong written and verbal communication and presentation skills.
  • Strong team player that has a customer service approach and is solution oriented. \
  • Must thrive working in a fast-paced, innovative environment demonstrating flexibility and a proactive approach. \
  • Excellent interpersonal and negotiation skills with the ability to develop important relationships with key stakeholders.

NOTE:  All candidates must be authorized to work in the United States.  Our client cannot provide H1B visa sponsorship or a transfer.

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