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Regulatory Affairs Manager

Role Objective

As Regulatory Affairs Manager, you will be responsible for leading and developing the Regulatory Affairs team at the Waterford site, supporting the Head of Scientific Affairs in activities relating to product registration globally and also support the Clinical Affairs team in achieving Regulatory Approval for global clinical trials.

Company/Culture

This company has an inclusive, friendly and patient-centric culture. They believe in fostering talent and developing employees from within. They have an open-door policy to ensure employee ideas are heard. Their employees all have an eagerness to learn and strive to deliver on commitments.

Key Responsibilities

As Regulatory Affairs Manager, your responsibilities will include:

  • Plan regulatory requirements for projects and ensure these are understood by team members in order to deliver pre-agreed targets within time-lines
  • Support Clinical Affairs team on responsibilities within clinical trials such as regulatory approval
  • Oversee licence maintenance support to customers and Regulatory agents
  • Manage licence activities for existing MAA's in Europe, US, Canada and Japan
  • Manage submissions to target markets
  • Coach and mentor team members
  • Assist with new hires whilst managing RA budget

Skills and Experience Required

  • Minimum B.Sc in Pharmacy, Chemistry or Pharmacology
  • 10 years of experience in Regulatory Affairs
  • People management/leadership experience

Give me a call to find out more or apply with an up to date CV!

To find out more about Real please visit www.realstaffing.com

Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales