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Job

Director, Regulatory Affairs - CMC

  • Location

    New Jersey

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Contact:

    Tim Viola

  • Contact email:

    t.viola@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Published:

    about 2 months ago

  • Expiry date:

    2022-01-31

  • Startdate:

    ASAP

Job Title:     Director, Regulatory Affairs - CMC

Job Location:    United States, Remote

Job Overview:          

Responsible for the delivery of or oversight and management of allocated projects, with a primary focus on CMC, including regulatory authority licenses, registrations, exemptions, designations, applications or authorizations for marketing and sale of a drug product or for the use of an investigational drug in human subjects. The Director will develop regulatory plans and strategies for emerging and mid-tier life science client companies. The position will also include client and regulatory authority liaison.  

Job Duties and Responsibilities:

  • Plans regulatory submissions for assigned compounds in various phases of clinical development, global marketing applications, and post-approval life cycle activities.
  • Develop, lead, and drive CMC regulatory strategy for development projects and marketed products with a focus on creativity and innovation, maximizing the business benefit balanced with regulatory compliance.
  • Emerging senior level position primarily devoted to development of strategic approaches to reconcile regulatory issues and expedite regulatory submissions
  • Lead and drive all CMC content for submission activities (planning, authoring, reviewing, coordination, submission) for across all stages of development for pharmaceuticals and/or biologics.
  • Serve as RA CMC liaison with the FDA and develop global regulatory contacts
  • Conduct and participate in meetings with regulatory authorities.
  • Establish, manage, and maintain a knowledge base of current and emerging CMC regulatory requirements, guidelines, and best practices, and interpret and communicate relevant issues to colleagues
  • Provide CMC regulatory expertise for new business development/due diligence activities.
  • Stay abreast of current and evolving regulatory CMC requirements, applies this knowledge to assigned projects, and shares knowledge and experience with others to support their development.

Experience

  • 10+ years’ of Regulatory Affairs CMC experience; or combination of work experience, education or other related industry experience in similar role.
  • Module 2 and Module 3: IND/NDA or IND/BLA authoring experience
  • Experience with both NDA and BLA a plus
  • Cellular or gene therapy experience a plus
  • Analytical chemistry background/experience preferred
  • Experience with FDA agency interactions is a plus

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