Senior Regulatory Affairs Manager

2 weeks ago

Dublin, United Kingdom Page Group Full time

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 a innovative growing privately held business. They have a portoflio of over 30 life changing products available in over 100 countried. care who are a privately held, fourth generation family owned pharmaceutical company.

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. They continue to bring to the world first to market innovative products focusing on gynaecology, fertility, obstetrics, endocrinologyand 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 needsand 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:

- 7 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)
- 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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