A leading pharmaceutical manufacturer requires a Regulatory Affairs Officer to join its team. As regulatory affairs officer, among other duties, you will be preparing, reviewing and authorising CMC (Module 3) documents. To be considered, you must have previous experience in reviewing CMC documents and knowledge of UK and EU regulatory requirements.
- Prepare, review and authorise CMC (Module 3) documents.
- Ensure an eCTD baseline is created for all the current authorised products using the current software.
- Maintenance of the departmental regulatory database
- Prepare, review and publish different variation (Type 1A, Type 1B and Type II)
- Assisting the Quality Assurance department in maintaining the QMS and various tasks and procedures (OOS, change controls, deviations, CAPAs etc).
- Preparation of UK/EU regulatory submissions (Type 1A, Type 1B and Type II)
- Archiving of national regulatory submissions and approvals, both electronic and hard copy.
- Provide regulatory advice to support the UK & EU strategy.
- Support and align with other departments/functions on needs re periodical requests. (e.g., tender support)
- Provide input to local cross functional teams on status of planned and approved regulatory submissions
- To comply with Health and Safety Regulations.
- To maintain the confidentiality of all information relating to the business activities of the Company (and sister companies)
- To attend relevant courses as demanded by the Company
- To perform other duties as directed by the Company.
- Extensive knowledge of CMC Module (Module 3).
- Experience in pre-approval activities, such as dossier review
- Handling of different types of variations.
- Knowledge of regulatory requirements UK and EU.
- Experience in using and maintaining the publishing software.
- High organisational skills and time management.
- Ability to manage multiple projects and multiple tasks in balance.
- Ability to work in a matrix environment.
Salary £28k - £32k
Job Ref: 6183