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Regulatory Affairs Manager

Location: Dublin South, Dublin
Salary: Negotiable
Posted: about 2 months ago
Role type: Permanent
Industry: Science, Technology and Operations Practice (STO)
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 pharmaceutical portfolio.

The Role

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

  • Submission of:
    • labelling changes based on the CCDS according to pharma SOPs.
    • quality related changes according to the agreed timeliness.
    • DSURs according to SOP and the local legislation.
    • applications for new Marketing Authorisation, line extensions and new indications.
  • Regular monitoring of the submission status with the authorities.
  • Timely update of internal and external databases and document management systems
  • Providing relevant information on RA milestones to GRA and other functions on the local level (Medical, PV, Product Supply, Business, Communication, Market Access, etc.).
  • Archiving of all documents and correspondence submitted to and received from the Authority according to the Global SOP and locally agreed processes.
  • Contribute to ensure that all local procedures comply with global directives and procedures.
  • Writes, reviews and approves documents applicable to this department, as described in the procedure on SOP management.
  • Give needed RA support to Quality Manager to perform the investigations and CAPA.
  • Ensures that the correct texts are used for the packaging materials as described in the procedures on repackaging and extra labelling activities
  • Provides guidance on regulatory obligations and company policies for the management of self-inspections
  • Has overall responsibility for the publication of SmPC and PIL for allocated products on the regulatory product information databases.

The Person

You will have skills and experience in the following:

  • BSc, MSc or PhD in life science or pharmacy.
  • Minimum 2 years' experience.
  • Experience in a national and/or regional registration procedure.
  • Fluency in English.
  • Requires adequate negotiating, interpersonal and influencing skills.
  • Commercial awareness, good project management skills and an ability to adapt to changing priorities.
  • 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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