WuXi AppTec

  • Senior Director Regulatory Affairs CMC

    Job Locations US
    Job ID
    2018-4278
  • Overview

    This position will work with project teams to assure that CMC decisions and planning, both operational and strategic, are designed to position products for successful regulatory filings. CMC projects of all areas will be put in the context of regulatory expectations to ensure the correct scope of work is pursued.

    This position will have expertise in development of all aspects of drug substance and product. A key deliverable will be to produce high quality technical documents to support regulatory filings, for example, dissolution method development and justification, and preparation of briefing documents. Technical reports such as validation reports and process development reports will also be written such that they will be written to provide clients with the most relevant information in their regulatory filing.

    Responsibilities

    • Develop and implement global CMC regulatory strategies from pre-clinical to late stage programs in line with client's business objectives.
    • Apply knowledge of US, EU and ICH regulatory requirements to provide strategic and operational CMC regulatory direction.
    • Articulate complex regulatory CMC issues and support global development and commercialization of early and late state programs.
    • Lead the preparation and submission of high quality documents via drafting, reviewing, editing of periodic development report, milestone reports, module 3 source documents to support investigational and marketing registration packages throughout the world.
    • Review 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.
    • Liaise and negotiate 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.
    • Proactively manage critical CMC issues, taking leadership for the regulatory contribution.

    Qualifications

    Technical Skills / Knowledge:

     

    Knowledgeable in major market and ICH guidelines relevant to CMC aspects of product development and maintenance.

     

    Ensures timely submission of appropriate regulatory documents in conjunction with Regulatory Operations.

     

    Independence/ Accountability:

     

    Must be self-motivated, able to respond effectively to changing priorities, and manage challenging assignments through collaboration, communication and teamwork.

     

    Must be highly organized, committed to excellence, and possess both determination and attention to detail.

     

     

    Communication Skills:

     

    Must have excellent collaboration, influencing and negotiation skills, and be able to establish and maintain collaborative working relationships with intra-department, inter-department, and external third party personnel.

     

    Ability to manage complex projects, timelines and teams in a matrix team environment. Excellent analytical and communication skills – both verbal and written. Ability to communicate effectively to multiple levels of the organization with strong negotiation skills.

     

    Customary Education and Experience:

    Masters or Ph.D. degree in pharmacy, biochemistry, chemistry, biology or related pharmaceutical field.

    8+ years of related experience within a pharmaceutical company (or equivalent technical experience) with minimum of 2 years relevant CMC regulatory experience in small molecule regulatory activities.

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