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Senior Regulatory Affairs Specialist

Reference ID : NHMBD4
Category :
  • Medical Devices
  • Science
  • General Manufacturing
  • Pharma / Biotech
Date Posted : Nov 16, 2017
Job Location
:
  • Munster
- Tipperary
Experience : 5+ Years
Salary : Neg
Employment Type
:
Contract
Consultant
:
Nicola O'Sullivan
Contact Number : 087 0622429
Senior Reg Affairs Specialist required for leading Munster based pharmaceutical multinational

Principal Responsibilities

Senior Regulatory Specialist

Career advancing opportunity within a global pharmaceutical leader based in the Munster region.  The successful candidate will provide regulatory support for the manufacture of clinical and commercial pharmaceutical products.

Key Responsibilities:

  • Regulatory point of contact between site and corporate regulatory personnel for clinical and commercial small molecules
  • Support corporate regulatory personnel
  • Provide regulatory direction to the site for products of responsibility
  • Support the plan and execution of regulatory strategies
  • Manage the site submission activities and timelines to support global filings
  • Maintain a working knowledge of current and emerging government and worldwide requirements for initial registration, re-registration and post approval changes
  • Provide input to project schedules in terms of regulatory activities
  • Review site technical reports when complete from a regulatory perspective
  • Provide support as required during HA inspections

Qualifications & Requirements

Qualifications and Experience:

  • Degree in Chemistry, Chemical Engineering, Pharmacy, Biological Sciences or related discipline
  • Minimum 5 years experience in the pharmaceutical industry – Regulatory experience in research development and/or manufacturing
  • 3 years regulatory/QA experience required in the pharmaceutical industry
  • Direct experience with regulatory submissions desirable
  • Strong knowledge of regulatory and compliance guidelines within the pharmaceutical manufacturing industry.

For more information and a full job spec contact Nicola on 087 0622429 or email your CV in the strictest confidence to jobs@headcount.ie  



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