Senior Regulatory Affairs Manager - Dublin, United Kingdom - Page Group

Page Group

Verified Company

Dublin, United Kingdom

3 weeks ago

Posted by:

Tom O´Connor

beBee Recruiter

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 youare 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, 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 lifecycle maintenance activities
Effectively plan, manage and deliver highquality 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 signoff
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.