Connecting linkedin

W1siziisimnvbxbpbgvkx3rozw1lx2fzc2v0cy9oyw1sew4td2lsbglhbxmvanbnl2jhbm5lci1kzwzhdwx0lwpvyi5qcgcixv0

Job

Director, Regulatory Affairs - CMC

  • Location

    New Jersey

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Salary:

    180k-220k

  • Contact:

    Tim Viola

  • Contact email:

    t.viola@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Published:

    3 months ago

  • Expiry date:

    2022-03-31

  • Startdate:

    ASAP

Director, Regulatory Affairs - CMC


In office in Northern New Jersey 3 days a week – Possibility of Remote for Candidates outside of New Jersey
 

Responsibilities

  • Provides strategic regulatory direction on general CMC regulatory strategies, regulatory requirements for clinical studies and marketing approval in domestic and international markets, regulatory strategic development plans and risk assessments, critical issue management and Health Authority interactions
  • Uses knowledge of US, EU and ICH regulatory requirements and the ability to apply knowledge both strategically and operationally to development projects and marketed product regulatory issues to support corporate goals
  • Able to articulate complex Regulatory CMC issues and support global development and commercialization of early and late state programs
  • Oversees and/or leads as necessary the preparation and submission of documentation to support investigational and marketing registration packages throughout the world and ensures timelines are met
  • Reviews CMC sections of IND/CTA, NDA/BLA/MAA, and other global submission documents in support of clinical trials and marketing applications, and their amendments in conformance with local regulatory requirements
  • Liaises and negotiates with global regulatory authorities as needed for all aspects pertaining to drug development including resolution of key CMC regulatory issues and to expedite approvals of product
  • Maintains awareness of global regulatory environment and assesses impact of changes on business and product development programs.

Experience:

  • Bachelor’s degree preferably in a scientific or technical field; advanced scientific-related degree preferred
  • Ten (10) years pharmaceutical industry experience with a minimum of five (5) years in regulatory affairs
  • Some expertise in the biologic drug development process and post approval activities is desirable
  • Experience leading teams, mentoring or managerial experience a plus
  • CMC experience in biologics preferred but not necessary
  • Expert knowledge of regulatory affairs CMC; FDA & EU guidelines and regulations with an emphasis registration requirements; experience with Rest of World submission requirements. Detailed knowledge of content and preparation of all regulatory CMC documents and experience in maintaining regulatory compliance within pharmaceutical industry.
  • Experience in leading teams and managing junior staff preferred

 

#LI-TV1