This Job Vacancy has Expired!

Regulatory Submissions Team Leader

Posted on Aug 21, 2020 by Real Staffing Group

Dublin, Ireland
Research
Immediate Start
Annual Salary
Full-Time


A Leader in the Pharmaceutical Industry is seeking a talented Regulatory Affairs Team Lead to undertake full responsibility of leading the submissions team.

You will be proactively managing the life cycle of the medicinal products and will be report directly to the companies Associate Head of Regulatory Affairs.

Responsibilities:



  • Lead the Regulatory Affairs submission team and coordinate team workload and activities.

  • Lead preparation of Module 1 documentation ensuring submissions and deficiency questions are properly handled with regards to new applications, renewal and variation procedures.

  • Monitor new legislations and train concerns internal stakeholders.

  • Liaise with external parties, Health Authorities of EU, customers and CMO's.


Requirements:

  • MSc or higher in life sciences.

  • 8-9 years of pharmaceutical (generics) industry experience.

  • Knowledge of EU regulatory requirements with focus on Module 1 documentation and eCTD submissions.

For immediate consideration please apply with an up to date CV.

Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | London, United Kingdom | Partnership Number | OC387148 England and Wales




Reference: 932398975

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