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Katalyst CRO

Regulatory Affairs Specialist

Katalyst CRO, Watertown

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  • The Genomic Medicine Unit Chemistry Manufacturing & Control (CMC) development organization is responsible for all aspects of drug development, from molecule/pre-candidate to product approval.
  • This encompasses drug substance (DS), drug product (DP) and analytical development, DS/DP clinical manufacturing, and support of global regulatory filings from IND submission to NDA approval.
  • This role will build and maintain relationships with scientific staff, lab champions, functional heads, leadership, and support services to foster trust, facilitate solutions, on all assigned operations.
  • They will facilitate efforts to overcome the obstacles and major roadblocks so scientists can succeed, while empowering them to function independently within the current operational workflows.
  • They will review the scope of the various support services to identify gaps and solutions based on the requirements of the site.
  • Facilitate coordination of disruptive activities required by workplace experience, real estate, or other initiatives coordinate to ensure science continuation.
  • Manage office and lab basic consumables including issuing PO's, tracking and invoice approvals, receiving, handling, & stocking.
Responsibilities
  • The Genomic Medicine Unit Chemistry Manufacturing & Control (CMC) development organization is responsible for all aspects of drug development, from molecule/pre-candidate to product approval.
  • This encompasses drug substance (DS), drug product (DP) and analytical development, DS/DP clinical manufacturing, and support of global regulatory filings from IND submission to NDA approval.
  • This role will build and maintain relationships with scientific staff, lab champions, functional heads, leadership, and support services to foster trust, facilitate solutions, on all assigned operations.
  • They will facilitate efforts to overcome the obstacles and major roadblocks so scientists can succeed, while empowering them to function independently within the current operational workflows.
  • They will review the scope of the various support services to identify gaps and solutions based on the requirements of the site.
  • Facilitate coordination of disruptive activities required by workplace experience, real estate, or other initiatives coordinate to ensure science continuation.
  • Manage office and lab basic consumables including issuing PO's, tracking and invoice approvals, receiving, handling, & stocking.
Requirements:
  • BS required in Life Science discipline or engineering.
  • Experience working with GXP integrated commissioning and qualification practices
  • Experience working within a regulated environment.
  • Experience with coordinating invasive operations from managing large capital projects/investments.
  • Solid understanding of Health, Safety, Environmental and Legal requirements for operations.
  • Clear operational experience in R&D and development laboratories.
  • Excellent communication and technical writing skills.
  • Demonstrated problem solving / trouble shooting skills.
  • Direct experience working in regulated environments, i.e., cGMP, OSHA, EPA, etc
  • Proficiency with Microsoft Office Suite, working knowledge of common intranet communication tools and business tools such as Concur, eBuy, EasyInvoice, and Workday.
  • Ability to grow and gain entry to laboratory, manufacturing, and mechanical areas.
Seniority level
  • Seniority level
    Mid-Senior level
Employment type
  • Employment type
    Contract
Job function
  • Job function
    Legal
  • Industries
    Pharmaceutical Manufacturing

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