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Senior labelling manager

Senior labelling manager

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Senior labelling manager

  • Location:

    England

  • Sector:

    Pharma

  • Contact:

    Harry Reeve

  • Salary:

    £40 - £55 per hour

  • Job type:

    Interim/Contract

  • Contact email:

    harry.reeve@msipharma.com

  • Job ref:

    VR/04222_1667215132

  • Published:

    about 1 month ago

  • Duration:

    6 Months

  • Startdate:

    ASAP

Responsibilities

Responsibilities

  • Monitor and develop continuous improvement proposals on the processes
  • Maintain a staff of adequately skilled resources to meet deliverables
  • Communicate issues and resolve them in an appropriate time frame
  • Ensure adherence to agreed-to work practices
  • Meet established submission timelines and quality standard.
  • Participate, as needed, on global teams to complete assignments and tasks within a specific task force/project associated with labelling
  • Ensure collection of metrics
  • Improve speed to minimize the cost
  • Identify discrepancies/issues in local implementation of corporate labels and contact the affiliates (if appropriate) for remediation actions

Qualifications we seek in you!

Minimum qualifications

  • Demonstrated knowledge and understanding of CCDSs, US and EU labeling, and the dynamics of Labeling Team purpose and objectives
  • Proven ability to successfully understand regulatory implications of product strategy with regards to the product label, assessment, and practical management of associated impacts
  • Ability to work well in cross-functional teams, exhibiting a combination of active listening skills and the confidence to guide decision-making for the document content strategy. Proficient in speaking publicly to senior management when required
  • Must be able to construct a Company Response (MAH response) for health authority questions
  • Masters in Life Sciences
  • Understanding of key regulatory and Labeling principles and SOPs
  • Should be open to work in any shift as per the business requirement

Preferred Qualifications

6-9 years' experience in Regulatory affairs

Proven and relevant regulatory affairs experience in pharmaceutical, vaccine, or biological products; or related fields.

Marketing authorization experience.

Proven Project Management experience