Description
The role on offer is for an experienced regulatory affairs manager with specific experience within clinical trials and EU Centralised product experience to work 5 days per week in Cambridge. The trial in question is a for a late stage respiratory study going to submission shortly in the future. The successful candidate for this position is someone who has worked within clinical trials submissions to the regulating bodies and has specifically worked on EU centralised products and MAA submissions.
Responsibilities include:
Submitting moderately complex regulatory documents including safety reports, amendments, supplements and license renewals to clinical trial applications in Europe and marketing authorisations for assigned territories (Mainly EU Centralised).
Ensuring product packaging and associated information is updated and maintained in accordance with the product license.
Acts as project team representative for specified products depending on complexity of the project.
Maintains knowledge of regulatory requirements up to date and communicates changes in regulatory information to project teams and senior management in a timely manner.
Knowledge/Experienced required
Direct experience working with Regulatory Authorities in assigned territories is desirable.
Excellent organisation skills and ability to work on a number of projects with tight time lines is required.
Must be knowledgeable of regulatory requirements, including ICH requirements and regional requirements for assigned territories.
Must be capable of developing and implementing regulatory strategy and of managing negotiations with Regulatory Authorities.
May take a leadership role in updating and preparing the Company for minor changes in legislation in assigned territories.
Allegis Group Limited and Aston Carter Limited operate Employment Businesses and Agencies and are companies within the Allegis Group Inc. group of companies, the fourth largest staffing company in the world, (collectively referred to as the "Allegis Group"). TEKsystems and Aerotek are divisions of Allegis Group Limited. Applicant data will be treated in accordance with the Allegis Group's Privacy Notice . By submitting personal data to any company or division within the Allegis Group, the applicant is providing explicit consent to the use of such data by the Allegis Group and to the transfer of such data to and from the Allegis Group companies within the UK, Europe and outside the European Economic Area in connection with the fulfilment of the applicant's voluntary requests, and the fulfilment of other job opportunities that match the applicant's profile, and confirms that they may be contacted about such job opportunities.