Senior Regulatory Affairs Officer

Location
Dublin (City), Leinster (IE)
Salary
Negotiable Depending On Experience
Posted
25 Mar 2021
Closes
24 Apr 2021
Ref
CN JO-2103-465419
Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

My client, a global pharmaceutical company with offices in Dublin City now have a new vacancy for a Senior Regulatory Affairs Officer.

Your role is to provide regulatory affairs support and manage International MAAs and Lifecycle activities for their current and actively growing range of pharmaceutical products, CAMs, R&D pipeline products’ therapeutic indications and international markets. Promote and facilitate team and corporate growth and success.

Key Responsibilities:

  • Acts as responsible Regulatory Team member for assigned regulatory projects (medicinal products, and ad hoc R&D pipeline)
  • Preparation and filing of submissions including life-cycle maintenance variations, initial MAA filling, labelling updates, renewals, obtaining CPPs, Marketing Authorisation Transfers (MATs) and publishing.
  • Prepares and/or reviews regulatory documentation for DCP, MRP and National applications in line with assigned timelines.
  • Support the strategic and operational planning and registration of CAMs in global markets.
  • Actively participates and employs effective communication practices with internal customers (CMC, CAMs team, Supply Chain, Quality, Legal, Clinical, Medical, Pharmacovigilance, globally based Regulatory Managers).

Qualifications/Experience:

  • >3 years pharmaceutical regulatory experience, focusing on lifecycle maintenance of marketed products in Europe and/or emerging markets (e.g., variations, renewals, new Marketing Authorisation Applications (MAAs) submissions)
  • Experience of EU DCP and MRP MAAs
  • Experience of emerging markets / international RoW markets and regulatory filings.
  • Quality control review of technical/ regulatory documents

Understanding of Regulatory strategy and determination of documentation requirements

Full Job spec available on request.

For full details contact Ciara at cnugent@thornshaw.com or call +353 1 2784671

Thornshaw Scientific Recruitment is a leading Irish Provider of Specialist Scientific Recruitment.  Part of the CPL group.   www.thornshaw.com

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