Regulatory Affairs Manager

Posted 10 February 2020
Job type Permanent
DisciplineLife Sciences & Engineering Technologies, Science Leaders & Specialists
ContactMaeve Fahey

Job description

This speciality pharmaceutical organisation focus on R&D and innovation in the space of women's and men's health. Due to a strong development pipeline for 2020, they are seeking an experienced Reg Affairs Manager to join the team at their Dublin City Centre facility.

The Role

Duties and responsibilities of the Reg Affairs Manager will include:

  • Act as responsible Senior Regulatory Team member for assigned regulatory projects
  • Effectively plans, manages and delivers assigned project workload
  • Preparation and responsibility for regulatory submissions including MA Transfer, CMC variation filling, initial MAA filling, labelling updates, renewals, publishing, CMC authoring and \ or updates as required in line with Corporate needs and timelines
  • Writing and preparation of relevant CTD documents to support submissions
  • Effective high-quality communication with Regulatory Authorities for assigned projects and on ad hoc basis
  • Responsible for understanding the Scope of Work, strategy, timelines and deliverables for a given project
  • Prepare monthly status reports and metrics for assigned projects
  • Promote best regulatory practice and approach in business operations
  • Promote and develop best use of regulatory tools and e-platforms
  • Support Change Control and Quality Management process within GRA

The Person

You will have skills and experience in the following:

  • BSc / Pharmacy degree
  • 5+ years human pharmaceutical regulatory experience, focusing on lifecycle maintenance of marketed products in Europe and/or emerging markets (e.g. variations, renewals, new Marketing Authorisation Applications (MAAs) submissions)
  • Experience of EU DCP and MRP MAAs
  • Experience of emerging markets / international RoW markets and regulatory filings
  • Project management experience
  • Experience of Women's and/or Men's healthcare - an advantage
  • Experience of US Regulatory Affairs - advantageous
  • Experience of Medical Devices - advantageous
  • Experience of Food Supplements/Borderline/Nutritional products - advantageous

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