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Senior Regulatory Affairs Manager

Employer
Michael Page
Location
Republic of Ireland / Dublin, Republic of Ireland
Salary
Negotiable
Start date
14 Nov 2022
Closing date
14 Dec 2022

View more

Discipline
R & D , Scientific
Hours
Full Time
Contract Type
Permanent
Experience Level
Management
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Job Details

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 :

  • >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.

Company

The original PageGroup brand, Michael Page is comprised of 25 disciplines – each providing a service to a specialist area of the market. We recruit permanent, temporary, contract and interim opportunities, typically from second/third job levels upward. Businesses we work with range from SMEs to global blue-chip organisations.

LinkedIn award

 

The UK

Our business started life in the UK in 1976, as a two-man operation above a laundrette. Nearly four decades later we have more than 7000 employees and a global office network, while growing our UK market coverage too.

With offices from Aberdeen to Bristol and Cardiff to Cambridge, and more than 25 specialist businesses we have the track record to handle your recruitment requirements or job search. We combine our local knowledge and global expertise to provide a specialised service to both employers and candidates.

Find Us
Website
Telephone
0845 6060 610
Location
Michael Page International Ltd,3rd Floor
The Switch Building
1‑7 The Grove
Slough
SL1 1QP
GB
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