Regulatory Affairs Officers

Kingston Upon Hull, England
Oct 03, 2016
Oct 31, 2016
Asia Asghar
Result Type
Position Type
Full Time


Do you have previous regulatory affairs experience from the Healthcare, Cosmetic or Medical Device industries?

Are you looking for an excellent opportunity to work for a leading company?

A number of opportunities currently exist with a leading healthcare organisation based in Hull for Permanent Regulatory Affairs Officers. Working mainly on assigned healthcare projects, you will be responsible for the development of the regulatory strategies with a commercial mindset in driving regulatory expertise and understand at feasibility and throughout the project.

You will be responsible for the creation and delivery of the product core dossier/ technical file relating to the project. Working with the dossier/ technical file authors to ensure consistency and 'right first time' approach, you will deliver dossiers/ technical files or other product information on time and in line with the agreed regulatory strategy.

Key responsibilities will include:
- Work in partnership with the local regulatory teams to identify and be aware of key requirements and that they are taken into account to deliver a 'right first time' approach to new product development
- Responsible for delivery of dossier/ technical file to agreed time frames and collaborate across partner functions to ensure timely delivery of all information required, to enable robust and consistent project updates
- Ensure high quality and accuracy of the dossiers vs the agreed requirements and highlighting of any potential issues, working with the authoring functions and local regulatory affairs teams.
- Supports work required to refine Regulatory processes and procedures to optimise accuracy and efficiency, thus enabling speed to market
- Provide through dynamic resourcing appropriate support (Subject Matter Experts) to the Innovation projects & team when assigned by manager.

Qualifications and Experience Required:
- Educated to honours degree level in a scientific field or equivalent experience
- Regulatory Experience and knowledge in NPD and dossier/ technical file creation and global registrations
- Regulatory experience from Pharmaceutical/ Healthcare/ Cosmetics or Medical Devices fields
- Knowledge of the Regional and Global regulatory environment and how it impacts regulatory dossiers and registration
- Experience in preparing and submitting dossiers, variations and renewals
* Ability to communicate requirements
* Understanding of global product development practice, rules, regulations and guidelines
* Familiarity with factors likely to influence the regulatory environment, including new and emerging guidelines relevant to dossier deliveries
* High level of accuracy in reviewing and authoring documentation
* Ability to consistently deliver to time, cost and quality standards in a high pressure environment
* Knowledge of submission processes and product life cycle management activities for various consumer product categories.

If you have previous experience as a Regulatory Affairs professional, please apply online with your updated CV or contact Asia Asghar on 07894 605358 for further information.

The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency. SRG, winners of the Recruitment Professional Awards 2011 'Best Company to work for' and 'Best People Development Business' awards, and the only "highly commended" company in the Annual Recruiter Awards for Excellence 2011, for 'Best Small Recruitment Agency to Work For'.