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Regulatory Affairs Manager

Location: Dublin South, Dublin
Salary: Negotiable
Posted: 12 months ago
Role type: Permanent
Industry: Life Sciences & Engineering Practice
Contact name: Maeve Fahey
Contact email: maeve.fahey@hrmrecruit.com

Job description

Our client, a Top 10 global healthcare and consumer goods organisation based in South Dublin, are seeking a Regulatory Affairs Manager to manage the domestic regulatory aspect of their Consumer Health portfolio.

The Role

Duties and responsibilities of the Reg Affairs Manager will include but are not limited to:

  • Ensure regulatory compliance and delivery of local milestones for the Consumer Health (CH) range of products in the portfolio.
  • Maintain PA licences for CH products registered with the HPRA via the National, MRP and Centralised routes e.g. submission of variations, renewals, responses to queries, PSURS, line extensions) etc.
  • Ensure timely submission of labelling update and implementation to pack (including artwork review and approval).
  • Adhere to local & Global SOP's, OI's and contribute to creation, review and update of same as required.
  • Support the CH business as required with Patient enquiries, switch applications, product launch activities etc.
  • Timely update of internal and external systems to ensure regulatory compliance as per the required process e.g. submissions database.
  • Review & generation of registration documentation to ensure good quality and a right first time approach
  • Ensure timely implementation of CMC updates
  • Archive all Regulatory related documentation
  • Develop and maintain good working relationship with Supervisor, other team members and cross functional colleagues

The Person

You will have skills and experience in the following:

  • Sc, MSc or PhD in life science or pharmacy.
  • Experience in national and/or regional registration procedure.
  • Minimum 2 years experience.
  • Fluency in English.
  • Must be able to work as a team, have excellent organization skills and attention to detail.
  • Requires adequate negotiating, interpersonal and influencing skills.
  • Commercial awareness particularly in the Consumer Health business is an advantage with the ability to adapt to a changing environment.
  • Knowledge of national and regional pharmaceutical regulatory requirements.

To discover more about this opportunity, apply now or contact Maeve Fahey at HRM on +353 1 6321885 for a confidential discussion.

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Maeve Fahey

Science Recruitment Consultant

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