J56148MidlothianPharmaceutical Biotechnology PermanentDependent on experienceFull Time29/05/2018Regulatory Affairs Regulatory Affairs – UK Regulatory Affairs – EU Regulatory Affairs – Global Regulatory Affairs – Clinical Regulatory Affairs -Operations Regulatory Affairs - Biologics Regulatory Affairs - Veterinary Regulatory Affairs Assistant
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We currently have an exciting opportunity available for a Regulatory Assistant to join a leading company based in the Mid Lothian area. As the Regulatory Assistant you will be responsible for support functions within the regulatory Affairs Department, providing assistance in the registration of a portfolio of medicinal products for the global marketplace. This role will provide administrative and regulatory support to the Head of Regulatory Affairs (HRA) and the regulatory team as a whole. The role will require maintenance of regulatory documentation and regulatory systems within the department; provide assistance with the preparation of regulatory submissions and track the progress of regulatory submissions for new and existing products. The regulatory assistant will work under the direction of the Senior Regulatory Manager (SRM) and Regulatory Managers (RM).
We will be looking for candidates with some of the following skills: Regulatory Affairs, Regulatory Affairs Assistant, Regulatory Administration, Animal Health, Pharmaceutical, Vaccines, Research and Development, regulatory documentation, regulatory submissions, GCP, GLP, GMP, FDA, UDSA.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Regulatory Assistant will be varied however the key duties and responsibilities are as follows:
1. Working with Regulatory Managers to prepare dossiers and submission documentation for the registration of medicinal products globally.
2. Assist Regulatory Managers in life cycle management of registered products.
3. Track the progress of regulatory submissions with regulatory authorities.
4. Assists the Senior Regulatory Manager and the regulatory team in the maintenance and archiving of regulatory documentation and the regulatory system.
5. You will receive training in all aspects of vaccine and pharmaceutical product development and regulatory requirements by Senior Regulatory Manager, Regulatory Managers and Head of Regulatory Affairs.
6. Communicates ideas for improving company regulatory processes with a positive and constructive attitude, and for developing this attitude in others.
To be successful in your application to this exciting opportunity as the Regulatory Assistant we are looking to identify the following on your profile and past history:
1. You will be educated to at least degree level in a life sciences related topic. In addition to this, some experience in regulatory affairs in the pharmaceutical or animal health industries is required.
2. Knowledge of the European registration routes, and knowledge of FDA and/or USDA registration an advantage.
3. Previous experience in research or development would be preferred. Knowledge and understanding of product development processes and knowledge of GCP, GLP and GMP would be an advantage
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for our talent development. We welcome applications for any applicant who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment processionals and scientists. We look forward to helping you with your next career moves.