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Senior Regulatory Affairs Manager

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2022-12-07 23:37:14

Job location Balbriggan, Dublin, Ireland

Job type: fulltime

Job industry: Manufacturing Operations

Job description

The Senior Regulatory Affairs Manager role will support the continued growth and maintenance of there portfolio of medicinal products. To take line-management responsibility to help grow the regulatory achievements and regulatory team.

Client Details

I have exclusively partnered with Besins Health care who are a privately held , fourth generation family owned pharmaceutical company. Besins focuses on transdermal delivery technology treatments and has 30 products available in over 100 countries. If you are looking for a company to join where you can directly make an impact to women's and men's lives then look no further. Besins continue to bring to the world first to market innovative products focusing on gynaecology, fertility, obstetrics, endocrinology and hormonal deficiency therapies.

This Senior Regulatory Affairs Manager role would report into the Dublin HQ.

Description

The Senior Regulatory Affairs Manager role will support the continued growth and maintenance of there portfolio of medicinal products. To take line-management responsibility to help grow the regulatory achievements and regulatory team.

  • Acts as responsible Senior Regulatory Team member and representative for assigned regulatory projects
  • Provide support to Regulatory leadership on Operational activities and Strategy
  • Manage and lead internal and external personnel on regulatory projects and life-cycle maintenance activities
  • Effectively plan, manage and deliver high-quality regulatory project support
  • Preparation and responsibility for regulatory filings; including Marketing Authorization 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.
  • Project finance: planning, maintaining tracking/oversight of external vendor fees, Regulatory Agency fees relating to assigned projects
  • Promote and develop best use of regulatory tools and digital RIM (Regulatory Information Management) platform
  • Support Change Control, Regulatory best practices and Quality Management processes within GRA

Profile

Senior Regulatory Affairs Manager will have experience with :

  • Proven experience of EU DCP and MRP MAAs
  • Understanding of Regulatory strategy and determination of documentation requirements, timelines, budgets and filing options
  • Compliance with SOPs, Change controls and regulatory best practices
  • Pharmaceutical artwork review and sign-off
  • Line Management experience
  • Experience of Women's and/or Men's healthcare - an advantage

Job Offer

  • Competitive Basic Salary
  • Great Benefits Package
  • Hybrid Working
  • Progression Opportunities
  • Most importantly you'll be joining a forward thinking innovative pharmaceutical company making a real difference to people's lives.

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