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Job

Regulatory Affairs Labeling Manager

  • Location

    Remote

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Contact:

    Antoinette Miller

  • Contact email:

    a.miller@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Published:

    4 months ago

  • Expiry date:

    2022-05-15

  • Startdate:

    ASAP

Essential Functions of the job:

  • Use knowledge of US, EU and ICH regulatory requirements to plan and manage assigned projects to support corporate goals.
  • Assist/lead the preparation and revision of Core Labeling documents (CCDS, CPIL).
  • Assist the global labeling governance process, including drafting of SOPs and Work Instructions
  • Assist/lead the coordination of the Labeling Committee process, documenting and tracking decisions and actions, and maintaining archives.
  • Assist/manage the entire labeling process and management of revisions, including assigning/tracking projects, workflow execution, and issue resolution.
  • Assist in the development and maintenance of the end-to-end (E2E) labeling process.
  • Build partnerships with key stakeholders from other functions to ensure that strategic business goals are met through the sharing of knowledge and expertise.
  • Maintain awareness of global regulatory environment and assess impact of changes on business and product labeling activities. Facilitate policy and development of standard interpretation with internal stakeholders.
  • Assist with the development and implementation of regulatory processes.
  • Other duties as assigned.

 

Qualifications:

  • Understanding of product labeling and regulatory requirements in the pharmaceutical industry and ability to manage global core labeling processes.
  • Strong business acumen and ability to make sound decisions that contribute positively to the business.
  • Proven ability to deliver on goals within a cross-functional team/partnership environment with a high level of professionalism.
  • Excellent oral and written communication skills are a must, as are superior planning skills.
  • The candidate should be detailed-oriented, a self-starter, and be comfortable with broad responsibilities in an entrepreneurial, fast-paced environment.
  • Regulatory Affairs Labeling experience is highly desired.

 

Education Required: Bachelor’s degree (BS/BSc or BA), preferably in a scientific or health-related discipline, with at least 3 years (Manager).