Project Manager - Regulatory Labeling, FDA Engagement, Combination Product

Project Manager - Regulatory Labeling, FDA Engagement, Combination Product

21 Jan 2024
California, Thousandoaks, 91358 Thousandoaks USA

Project Manager - Regulatory Labeling, FDA Engagement, Combination Product

Vacancy expired!


Job Description:

SMCI is seeking a Regulatory Labeling Core Content Sr. Associate to support the Operations (Ops) and RL Core Content Leads (CCLs) in the new Final Product Platform Governance (FPPG) business process. The Regulatory Labeling CC Sr. Associate will be accountable for completing assigned / delegated core content deliverables on-time and in a manner commensurate with company s quality standards.
Education / Experience Qualifications:

  • Doctorate s degree and one (1) year of Pharmaceutical or Biotechnology Chemistry, Manufacturing and Controls (CMC) Regulatory Affairs experience; OR
  • Master s degree and three (3) years of Pharmaceutical or Biotechnology CMC Regulatory Affairs experience; OR
  • Bachelor s degree and five (5) years of Pharmaceutical or Biotechnology CMC Regulatory Affairs experience

    Preferred Qualification Criteria -
  • Minimum educational qualifications and 3 or more years of experience working in Pharmaceutical or Biotech supporting global labeling or regulatory affairs.
  • Experience in developing/maintaining global labeling documents (e.g. Instructions for Use (IFU), carton/container label)
  • Experience in drug delivery device development, manufacturing, or supply chain management
  • High level of proficiency in Word, Excel, PowerPoint, Microsoft Project
  • Ability to build professional networks, foster collaboration, work effectively within cross-functional teams, and consistently complete assigned deliverables on-time
  • Demonstrated strong oral and written communication skills
  • Demonstrated strong interpersonal skills
  • Demonstrated time management and decision-making skills
  • Demonstrated Ability to manage in a highly fluid, interactive, matrix environment.
    Required Skills: Regulatory Labeling; FDA Engagement; Combination Product.

    Don't hesitate! Submit your resume today.

    SMCI is an EEO employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, national origin, disability, age, genetic information, marital status, military, and veteran status. Members of minority groups, Vietnam Era Veterans and individuals with mental or physical disabilities are encouraged to contact us regarding employment opportunities. In addition, in order to support the provision of business to minority-owned and Women-owned businesses (MWBE), such MWBE are encouraged to contact us regarding subcontracting business opportunities with our firm.

    (No third parties, please)
    (H1 sponsorship currently unavailable)
    (Local candidates only, please)

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    Job Details

    • ID
      JC8428737
    • State
    • City
    • Job type
      Contract
    • Salary
      Market
    • Hiring Company
      Software Management Consultants, Inc.
    • Date
      2021-01-20
    • Deadline
      2021-03-21
    • Category

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