Senior Regulatory Affairs Associate

Company
Usurpo
Location
Remote in the UK or office based in Central London
Salary
Up to £50,000 plus bonus and benefits
Posted
20 May 2021
Closes
19 Jun 2021
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Title: Senior Regulatory Affairs Associate

Location: Remote in the UK or Office based in Central London 

Salary: Basic salary up to £50,000 (with some flexibility) + Bonus, pension etc. 

 

The Company 

As a world leader within the Consumer Healthcare space, this company has created some of the most recognisable brands in the world in various categories including pain management, Cough & Cold, Oral care, weight loss and health supplements. They are a large, international company in a strong financial position, meaning that there is certainly a strong element of stability whilst also having the benefit of working in an agile, fast paced affiliate. 

The Opportunity 

Reporting into one of their experienced Regulatory Affairs Managers, you will work as a key part of an experienced regulatory team to achieve successful product approvals, license maintenance, new claims development etc. A big part of the role will be to work as a partner to the commercial teams, working together to develop artwork, packaging and claims materials that are compliant to UK regulations. This is a great opportunity for any commercially astute Regulatory professionals who would enjoy working closely with commercial functions as a partner. 

One important point to make is that in this business, regulatory is genuinely seen as an enabler and business partner, rather than what is often the case of RA being seen as a roadblock by other functions. This allows for true partnership and meaningful collaboration between RA and the other functions across the business. 

 

Main duties and responsibilities include:

  • Create and support the development of regulatory strategies for new MAAs and product lifecycle maintenance activities.
  • Manage, execute and coordinate new MAA applications and product lifecycle maintenance activities (including variations, renewals and safety updates).
  • Support the management of products including product name strategy, the production of product information texts, review of claims, global advertising material and pack design.
  • As part of the team ensure product registrations are correct and compliant with the relevant legislation.
  • Liaise with local affiliates, responding to regulatory queries and providing and review of registration documents as necessary for the European territories.
  • Communicate with local and international regulatory authorities regarding applications and compliance issues.
  • Interpret and implement (inter)national legislation, follow changes in (inter)national regulations and legislations and proactively manage impact of these changes.
  • Participate to category and/or product meetings
  • Analyse regulatory issues and inform relevant stakeholders of developments in national and EU regulations and legislation and provide regulatory intelligence.
  • Assist in the process of reporting and investigating critical nonconformities and opportunities for improvement.

To find out more, please contact Christopher Gibson at Usurpo - cgibson@usurpo.com or apply to this advertisement with your CV.

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