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Regulatory Compliance Specialist

  • Job reference: 929767
  • Location: Cork
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Life Sciences, Quality, Compliance, Regulatory Affairs
  • Date posted: 03/02/2020

Orion Group Sciences have an exciting opportunity for a Regulatory Compliance Specialist for our Multinational Pharmaceutical client based in the Cork area on an initial 12-month contract.
Job Purpose

This position is responsible for supporting tasks and projects related to management of Regulatory Compliance and new product submissions. These activities include QA/Compliance support for worldwide submissions of new drug applications and post approval changes, change control support, manufacturing support and manufacturing license maintenance.

Main Responsibilities of the role

  • Point of Contact to request, source and provide relevant regulatory documentation (e.g. SOPs, Technical Reports, Deviations, Quality Agreements) to support miscellaneous regulatory requests such as paper-based inspections (e.g. Taiwan, Japan etc.)
  • In collaboration with Regulatory Management, ensure maintenance of the commercial and clinical manufacturers licenses
  • Notarization and legalization management
  • In collaboration with Regulatory Management, works on completing country specific registration, re-registration, accreditation requests
  • Co-ordinate SMEs for reviews of new product and post approval variations submissions to ensure that the sections are accurate and consistent across all products
  • Works with the Regulatory Manager to ensure Regulatory Playbook is maintained and updated in line with current product workflows
  • In collaboration with Regulatory Management, coordinating the Change Summaries for submission in the product Annual Reports, as required
  • Familiarization with license content and license sections in eCTD viewer and work with both the QPs and Regulatory Manager to ensure transparency of information and escalation information is shared
  • Regulatory support for routine manufacturing / Quality operations

Desired Experience and Background of the successful candidate

  • Knowledgeable on regulatory systems such as ERIS, RIACS, GRAIL, RIMDocs, eCTD, etc.
  • 3-4 years' experience
  • Collaboration and team work
  • Problem solving and attention to detail
  • Customer focused
  • Clear communication skills
  • Adaptable and flexible

    #pharma #medical #multinational #product #NPI #RegulatoryAffairs #QA

For more information on this role, call Daniel Ryan on +353868140295 or email Daniel.Ryan@orioneng.com for a completely confidential chat about this role and other opportunities using the reference number: 929767


Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.

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